Health product recall

Thunderbeat Type S Hand Instruments

Last updated

Summary

Product
Thunderbeat Type S Hand Instruments
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 catalog number
Thunderbeat Type S Hand Instruments All lots. TB-0520FCS TB-0535FCS TB-0545FCS

Issue

Olympus has been made aware, via customer feedback, of reports where probe tips of the Thunderbeat Type S hand instruments are becoming damaged or are breaking, as well as instances of pad damage or detachment. These issues can occur when the instructions and warnings in the IFU are not followed, specifically, taking very large bites of tissue, contact with metal while activating, and activation without tissue between the jaws.  The purpose of this letter is to reiterate the importance of these instructions and warnings to reduce occurrences of probe damage/breakage and pad damage/detachment. 

Recall Start Date: December 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76796

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