(b)(4).Date sent: 3/5/2024.D4: batch # a9ec8k.Additional information was requested and the following was obtained: "the surgery was a laparoscopic colectomy.The device was used on the ileocolic artery.No broken pieces fell off." "how did device not work? the device broke.Which part of the device broke? was the jaw broken? yes.Was the handle broken?=>no.Was the shaft broken? " investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired, and the clips did not advance into the jaw.The device was noted to have the tip of the advancer bent.The instrument was disassembled, upon disassembly the advancer was confirmed to be bent and ten(10) clips were found inside clip track.The jaws were visually inspected and no damaged was found.The event reported was confirmed and it is related to improper use of the device.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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