Health product recall

Olympus Resection and Inner Sheaths

Last updated

Summary

Product
Olympus Resection and Inner Sheaths
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

OES Pro Hysteroscopy Sheaths

More than 10 numbers, contact manufacturer.

A42011A

OES 4000 Urology Resectoscope System

More than 10 numbers, contact manufacturer.

A2660T

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A2641

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A2660

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A2642

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22014T

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A2666T

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A2666

ORS 4000 Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22014A

OES Pediatric Urology Sheaths

More than 10 numbers, contact manufacturer.

A37004A

OES 4000 Hysteroscopy Sheaths

More than 10 numbers, contact manufacturer.

A4741

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22041T

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22042A

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22043A

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22040A

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

WA22017A

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22041A

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22042T

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

WA22017T

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22040T

OES Pro Urology Resection Sheaths

More than 10 numbers, contact manufacturer.

A22043T

Issue

Olympus has identified complaints related to the ceramic tip of the resection/inner sheath breaking. Olympus is highlighting the importance of strictly adhering to the 'inspection and testing' and 'caution' sections in the IFU for the resection/inner sheath, and the 'inspection before each use' section in the resectoscope system manual.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Olympus Winter & Ibe Gmbh
Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81489

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