This reportable injury was identified during a review of complaints received between october 2017 and december 2019.Through review and communication from the surgeon, the likely cause is that a larger clip should have been used on the vessel.The two suspect clip appliers were returned to genicon, and found to function normally; there were misalignments or other issues present.
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Distributor has received complaints from their customers that clips, part number 350-000-103 and lot number 026214, which they purchased in (b)(6) (2018) aren't safe because they torn and make traumas in arteries and bile ducts.They caused a lot of bleedings inside the body.Customer believes the clip applier is either part number 350-010-002, lot number 07161229 or lot number 07161230.
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