Ethicon Proximate Stapler Recall Issued Due to Risk of Misfire

In response to reports where doctors have had problems with Ethicon Endo-Surgery staplers, more than 500 lots of the Proximate surgical staplers have been recalled. 

The Ethicon Proximate recall was announced last week by the Johnson & Johnson subsidiary, following complaints that the surgical staple guns were too hard to fire.

In one case reported to the FDA’s adverse event reporting system, a surgeon abandoned attempts to use the Proximate due to difficulty firing it. After one misfire, the suture was still attached to the stapler and had to be cut. The doctor had to perform a manual hemorrhoidectomy.

At the time that report was filed, in April, the company said it had checked the device and it appeared to be working fine. However, the company now says that the recall is due to the difficulty in firing the device, “which may result in incomplete firing stroke, that may result in an incomplete staple formation.”

The recall affects more than 500 lots of the Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, with a product code of PPH03, and the Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm, with a product code of PPH01. All of the affected devices have an expiration date of March 2016 to June 2017. There is also a full list of lot codes in the recall notice.

The company has requested that doctors check their inventory to see if they have Proximate surgical staplers affected by the recall. Ethicon asks that health care professionals not use the affected staplers and has asked that they be returned by November 5, 2012. The company has said it will issue credit for all Proximate staplers affected by the recall returned by that date.