Recall of PENTAX DUODENOSCOPE

Recall

30529

II

2017-03-14

Canada

HC

During interactive discussions with us fda concerning a 510(k) additional information ("ai") request for the ed-3490tk duodenoscopes the fda requested that pentax perform a root cause analysis to determine how soiling occurred on the surface of the suction cylinder and under the distal cap during testing. fda also requested that pentax identify risk mitigation strategies to address the manufacturing process possible damage to the duodenoscope with use and any other aspects of risk mitigation. as a result of the communications with fda and at the suggestion of fda it was decided that pentax would issue a customer safety communication to advise customers who use ed-3490tks about a potential issue associated with the distal cap and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. specifically the user communication states "during manufacturing of ed-3490tk duodenoscopes silicone adhesive is applied to the distal tip prior to affixing the distal cap. in some instances cracks or gaps may form in the adhesive that may be vulnerable to fluid ingress and soiling." the letter reminds users of the importance of using the ed-3490tk in accordance with its current labeling and assuring that all reprocessing personnel are knowledgeable and thoroughly trained on the current ifu for manual reprocessing of these devices. additionally the letter recommends that users "immediately remove from use any ed-3490tk duodenoscope that shows visible signs of wear or physical damage" and states that pentax will provide on-site inspections to assess duodenoscope functionality with particular attention to the integrity of the distal cap and provide in-house servicing as needed.