Back in August Ethicon’s Endosurgery division announced the voluntary recall of certain of its staplers, namely the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH03) and PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH01). We covered the tale here.
Now that recall has been elevated to FDA class I status and seen the addition of the company’s Transtar Circular Stapler Procedure Set (Product Code: STR10).
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. At the time of its voluntary action the company was sounding less than convinced that the problem lay with its device, hinting at user issues and the fact that supposedly faulty devices, when returned to the company, worked fine when reloaded and fired correctly. Sadly for the company, that the device could be incompletely operated, with its associated risk of a range of nasty consequences for the patient, means it had little choice but to take this one on the chin.
Indeed things have clearly moved on in the last few months, FDA not issuing Class I recalls unless by definition the fault is likely to result in serious adverse health consequences, including death.
Full details of the FDA recall can be found here and includes details of how to return the device to the manufacturer.