(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and the device: what is patient's current status? to date, no response has been provided and no device has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent.
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It was reported that during a transoral tumor removal, ligaclips slipped from ligated vessels.Because of post-op bleeding patient needed to be operated again on (b)(6) 2019.Clip applier used with clips was karl storz germany 8665l laryngo force, another manufacturers clip applier.This clip applier was inspected prior to use for proper jaw alignment, however, the lc800 was not used to load clips.The clips were used directly from clip magazine.There were no differences in loading the clips or applying the clips.Clips were noted to be partly crossed during the initial procedure.It is unknown if the same clip applier had been used during the initial procedure and reoperation procedure.After initial procedure, patient complained of pain.It is unknown if any precipitating factors such as coughing occurred prior to occurrence of bleeding and reoperation.At reoperation, new ligaclips were placed.Patient's current status is unknown at this time.
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