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Safety Alerts and Communications

Safety Alerts

Safety Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.

Medical Device Safety Alert: Wilson-Cook Medical Inc Instinct Plus Endoscopic Clipping Device

15 Nov 2024

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Wilson-Cook Medical Inc Instinct Plus Endoscopic Clipping Device [Reference part Number: INSC-P-7-230-S] [HKMD No.: 240315].

According to the TGA, the manufacturer has received reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle. The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire. The clip will extend from the catheter, but it will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs.

Potential adverse effects to the patient that may occur if the clip does not deploy as intended are injury (bleeding, laceration, perforation, etc.) requiring additional interventions. Potential adverse effects to the patient that may occur if there is a significant delay in the haemostasis procedure are additional interventions or medications needed to stabilise the patient, bleeding requiring additional haemostasis, surgical intervention, hospitalisation, or death.

For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-01006-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 Nov 2024

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