| 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 |
|
| 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 |