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Catalog Number EL5ML |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure, one device the clips were placing sideways when loading and the other device the jaws would not re-open after firing.No patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 8/17/2023.D4: batch # unk.Additional information was requested and the following was obtained: "what is meant by "clips were place crooked in applier did device not feed clips? did device drop or eject clips? did device sideways feed clips?"? they could not be placed correct in the device" attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "was the device locked on tissue or vessel? was the device difficult to open? how was the device removed? did the device eventually open? if other, please specify" attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).Date sent: 10/5/2023 d4: batch # a9cx79 additional information was requested and the following was obtained: "no further information available" 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; upon visual inspection, two(2) clips were noted to be jammed.The clips were removed in order to perform functional testing.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 6 clips were found inside clip track.However, it is known from the history of the device that bent advancer condition may lead to malformed clips.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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