Immediate actions for health services
The TGA has issued a product defect correction for the Ethicon ILS circular staplers.
If your service is using Ethicon ILS circular staplers, you should:
- examine inventory immediately and quarantine and return all ILS circular staplers as per instructions in the customer letter
- use an alternative circular stapler if available (Where alternatives aren’t available, consider usage on a case by case basis and whether it is clinically appropriate)
- where required, seek an alternative device. Health Purchasing Victoria can provide advice on this.
Circular staplers are designed to promote healing, provide more tissue control and lessen tension on the anastomosis. They are most commonly used after bowl resection, or bowel and oesophageal surgery.
Johnson & Johnson Medical distributes ILS circular staplers to 85 per cent. of the Australian market. An investigation by Johnson & Johnson Medical regarding complaints and returned products has confirmed occurrences of uncut washers and malformed staples with the Ethicon ILS circular staplers, which can compromise staple line integrity.
If problems with staple lines are not properly identified or addressed, there is a potential risk of post-operative anastomotic leak, gastrointestinal injury, haemorrhage, or haemorrhagic shock. Ethicon has received reports of serious adverse events, including deaths related to the malformed staples. The TGA has not been notified of any patient harm resulting from the use of this device.
Risk to patient safety
Given how widely ILS staplers are used in our health services, the risk of malformed staples causing serious patient harm is probable. Users are alerted to this issue to ensure situational awareness.
Based on Ethicon’s analysis of complaints received and estimated device usage, the predicted occurrence of complaints for malformed staples has increased but is expected to remain below 0.1% (the occurrence rate has increased from 0.03% to a predicted rate of 0.05%). Ethicon is implementing corrective actions to resolve the shift in product performance.
Please refer to the customer letter, attached below, or contact:
(03) 9096 2731
Last updated 04 Apr 2019