The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.
Initiated last month, the recall involved a total of 92,496 Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Intraluminal Staplers designed to enable creation of connections between structures in surgical procedures.
The devices were found to have uncut washers that indicate a complete 360-degree staple line failure. In addition, the staplers caused malformed staples because of insufficient firing, which could impact staple line integrity.
An investigation revealed a shift in a manufacturing process which occurred in March 2018 and continued through 8 March 2019, at which time the line was shut down.
FDA warned that the use of these intraluminal circular staplers could lead to serious patient harm or death. Misfiring of the stapler was responsible for serious injuries to two patients, confirmed Ethicon.
A statement from the US regulator read: “Misfiring of the stapler resulted in an additional resection – of the middle rectum in one patient and the lower rectum in another patient – during the planned resection of the upper rectum.”
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The FDA added that potential risks to patients include death, sepsis, bleeding, leak in the closure additional surgeries, need for additional closures and need for antibiotics.
According to a warning issued by the regulator in March this year, the number of adverse events associated with surgical staplers and staples for internal use is increasing.
An analysis found more than 41,000 individual medical device reports for surgical staplers and staples from 1 January 2011 to 31 March 2018.
Reuters noted that the FDA will hold an advisory committee meeting on 30 May to discuss if surgical staplers could be reclassified as Class II medical devices for internal use.