Boston Scientific Urgent Device Notification - Non-Sterile Devices Stolen and Risk of Infection - Notice to Hospitals

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This is duplicated text of a letter from Boston Scientific.
Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Non-Sterile Devices Stolen and Risk of Infection

May 3, 2011

Dear Risk/Materials Manager and Healthcare Professional:

Please distribute to the relevant Departments of Surgery; Emergency Medecine, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.

Subject: Urgent Device Notification - Non-Sterile Boston Scientific Devices Stolen and Risk of Infection

Boston Scientific Corporation is alerting you about a stolen shipment of Endoscopy and Urology / Women's Health medical devices. These devices were stolen while en route to our sterilization facility sometime between April 8, 2011 and April 11, 2011.

The labels on these devices state that they are "Sterile"; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.

Required Actions

• Check your inventory for affected product
• Segregate
• Monitor all incoming shipments for affected product

It is recommended that health care professionals monitor and treat patients for adverse events, such as post-operative infection, if they suspect or know that the below stolen non-sterile devices have been used.

Only the specific UPNs and Batches identified in the table below are affected. If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, please do not use the devices and contact John Zagala (Quality Assurance) at Boston Scientific at (905) 696-1923 or via email at john.zagala@bsci.com.

Please visit our website at www.bostonscientific-international.com or www.bostonscientific.com for information on device labeling, device photos and other additional information concerning this issue.

Below is the list of affected devices, including Device Description, Material/UPN/Catalog Number and Lot/Batch Number.

Device Name	Device Description	Material/UPN/ Catalog Number	Lot/Batch Number
Resolution™ II; 155cm Box 20	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522502	ML00000042
Resolution™ II; 235cm Box 10	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522511	ML00000043
Resolution™ II; 235cm Box 20	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522512	ML00000040
Resolution Clip™; 235cm (single unit)	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522610	ML000019C2
Resolution Clip™; 235cm Box 10	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522611	ML000017C2
Resolution Clip™; 235cm Box 10	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522611	ML000018C2
Resolution Clip™; 235cm Box 20	Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations.	M00522612	ML000020C2
Pinnacle™ Pelvic Floor Repair Kit	Pelvic Floor Repair Kit: Kits used for Pelvic Floor Repair of Pelvic Organ Prolapse	M0068317050	ML00000034
Flexiva™ 365 High Power Single-Use Laser Fiber; Box 5	Fiber optic laser energy delivery devices	M0068403921	ML00000046
Flexiva™ 550 High Power Single-Use Laser Fiber	Fiber optic laser energy delivery devices	M0068403930	ML00000060
Flexiva™ 1000 High Power Single-Use Laser Fiber	Fiber optic laser energy delivery devices	M0068403940	ML00000048
AccuMax ™ 365 Single-Use Holmium Laser Fiber	Fiber optic laser energy delivery devices	M0068404020	ML00000061
Advantage™ System (single unit)	Implantable mesh slings used for stress urinary incontinence	M0068502000	ML00000035
Advantage™ System Box 5	Implantable mesh slings used for stress urinary incontinence	M006850200051	ML00000036
Advantage Fit™ System Box 5	Implantable mesh slings used for stress urinary incontinence	M0068502111	ML00000038

Health Canada has been notified of this issue and is working with the Boston Scientific Corporation to recover these stolen devices.

Your vigilance related to any suspicious transactions relating to the devices listed above is greatly appreciated. For example unusually low pricing may be an indication that the product has been stolen.

Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the devices identified above, after the date of the theft, is encouraged to contact John Zagala (Quality Assurance) at Boston Scientific at (905) 696-1923 or via email at john.zagala@bsci.com.

If you have questions or concerns regarding the affected devices, contact the person named above at Boston Scientific.

Sincerely,

original signed by

John Zagala
Quality Assurance Canada
(905) 696-1923
(905) 696-1896