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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01240-1
Product Name/Description THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)

Multiple Models affected

ARTG Number: 209954
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/11/2013
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue The manufacturer has received complaints of damage to the THUNDERBEAT hand instruments during surgical procedures.

These complaints involve the following or a combination of the following descriptions:
- Cracking and deforming of the THUNDERBEAT probe tip/jaw
- Partial Separation of the PTFE (teflon) Pad
- Exposed Metal Part due to severe wear of the PTFE pad

Probe damage detected during surgery will trigger audible and visual generator alarms.
Recall Action Recall for Product Correction
Recall Action Instructions Olympus Australia is providing additional user instructions on procedural techniques to prevent damage to the Thunderbeat hand instruments.
Contact Information 1300 132 992 - Olympus Australia Customer Service