Is Ethicon Endo Hinting At User Issues As It Recalls Proximate PPH Pile Gun?

In short

J&J subsidiary business Ethicon Endosurgery has issued a voluntary recall of certain lots of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH03) and PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH01). The recall was provoked by reports of difficulty firing the device which, according to the recall notice, may result in incomplete firing stroke with consequential incomplete staple formation.

Background

Ethicon Endo’s voluntary recall is being targeted at Operating Room supervisors who are being asked to locate, stop using, account for and/or return what amounts to several pages of lot numbers of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH03) and PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH01). Specific lots affected are included on the recall notice, which can be found here, and extends to all lots with expiry date March 2016 to June 2017.

According to MassDevice, the recall notice hasn’t yet been filed on the FDA website, but dozens of incidents relating to the products have been logged on the agency’s MAUDE adverse event reporting system. It seems the issue relates to the firing and therefore dispensing and forming of the staples, although Ethicon itself has yet to confirm the existence of any material problem, hinting that the resolution may lie with the user, stating in one report that “if the firing sequence is not complete staples could be partially deployed without cutting the washer”. It went on to reload the same device and fire it successfully.

At the present time the recall is being conducted on a voluntary basis by Ethicon although the company is keen to point out that it is being undertaken with the full knowledge of the U.S. FDA.

So where next? Well the company has certainly gone to town by issuing such an extensive recall. It’s also time limiting it to November 5th for credits, but what it’s not doing is telling us it has the problem sorted at the present time. Whether there’s a quick fix is  unknown… while it’s possible that all we’ll see is the same product with additional warnings, this seems unlikely. It looks like additional fail-safe measures will be required to prevent the staple firing sequence from being partially performed.

Source: Ethicon Endosurgery, MassDevice, FDA