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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01601-1
Product Name/Description Conmed GS2000 - 50L Abdominal Insufflator
(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)

Affected Serial Numbers: 90869KZD and 91114CAD

ARTG Number: 233786
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/12/2016
Responsible Entity ConMed Linvatec Australia Pty Ltd
Reason/Issue The reason for this recall is that the device could cause a patient overpressure situation without any visual or auditory indication or warning from the device. If specific conditions occur, the affected unit could create an overpressure which is transient and reversible, requiring intervention from medical staff. If the device were to fail, the surgical attendants, anaesthetist or doctor would see an over -distension of the pneumoperitoneum or difficulty in patient breathing. The manufacturer has received one adverse event report overseas where the device caused an overpressure situation.
Recall Action Recall for Product Correction
Recall Action Instructions Conmed is advising users to immediately check their facility for the affected unit(s) and to contact Conmed, who will in turn organise collection of the affected unit and return of the corrected unit. If necessary, Conmed will provide a loaner device whilst the product correction is undertaken.
This action has been closed-out on 22/03/2018.
Contact Information 1800 238 238 - Conmed Australia Customer Service