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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01158-1
Product Name/Description Cystoscopy Bridges

Bridge, one way

Model Number: A20976A
Lot Numbers: 14XW, 152W, 153W, 154W, 156W, 158W, 15YW, 164W, 165W, 169W, 16XW, 172W

Bridge, two way

Model Number: A20977A
Lot Numbers: 148W, 149W, 14XW, 14YW, 14ZW, 154W, 155W, 156W, 159W, 15XW, 163W, 166W, 169W, 171W

ARTG Number: 146365
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/09/2017
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue The manufacturer OWI has received complaints about fragments of adhesive detaching from the inside of the working channel of cystoscopy bridges.

Chipping, cracking and delamination of the adhesive may occur when inserting an instrument through the working channel. In the rare occurrence that an adhesive fragment may fall in to the patient it can be flushed out with irrigation fluid or passed naturally. The retrieval of large adhesive fragments may require additional surgical treatment and extended anaesthesia. To date, there have been no reports of adverse events or patient injury related to this issue worldwide.
Recall Action Recall
Recall Action Instructions 1. Users with affected lots should continue to use existing Cystoscopy Bridges until replacements are obtained.
2. Complete and return the supplied reply form to Olympus.
3. Check the delivery details and number of affected devices listed in the customer letter that need replacing from Olympus, and contact them on 1300 657 699 with any changes.
4. Upon receipt of the replacement Cystoscopy Bridges from Olympus dispose the affected bridges and use the replacement devices.
5. Users who have distributed or transferred any of the affected products to other facilities should forward this recall notice and please notify Olympus so that they can follow up with that facility directly.

This action has been closed out on the 25/09/2018.
Contact Information 1300 657 699 - Olympus Customer Operations