Surgical staplers: TGA reviews device incident reports
Health facilities and staff are reminded of the importance of following the Instructions for Use (IFU) for surgical staplers after the TGA reviewed Australian Device Incident Reports (DIRs) associated with the devices.
The TGA reviewed the DIRs associated with 47 devices supplied by 13 Australian sponsors after the US Food and Drug Administration (FDA) issued a letter to health care providers and a news alert about these devices.
The FDA communications reminded providers to review labelling instructions and indications for use for surgical staplers and implantable staples, such as choosing the appropriate staple size for the patient's tissue type and thickness. The FDA letter to health care providers also suggested considering alternative options if the patient's tissues were swollen, prone to bleeding, or necrotic.
In the alert the FDA announced plans to consult on whether to re-classify surgical staplers for internal use as Class II medical devices, up from the current Class 1 status in that country. The situation in Australia is different in that surgical staplers are already regulated as a higher-risk classification, Class IIb or Class III.
The FDA cited 'an increasing number of medical device reports' involving surgical staplers in the US, however the TGA can confirm that in Australia reports remain relatively steady and in-line with expectations.
Surgical staplers and staples may be indicated for use in a wide range of surgical applications, including gastrointestinal, gynaecologic and thoracic surgeries. They can make procedures easier for surgeons and potentially shorten procedure time compared to manual suturing.
The most commonly reported problems in DIRs include opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure to fire and misapplied staples. Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional interventions.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS) or contact the TGA's Devices Post Market Monitoring Section on 1800 809 361.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.
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