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Catalog Number LT200 |
Device Problems
Device Slipped (1584); Failure to Form Staple (2579)
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Patient Problems
Pain (1994); Blood Loss (2597); No Code Available (3191)
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Event Date 09/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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It was reported that during a transoral tumor removal, ligaclip 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 (b)(4) 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 ligaclip were placed.Patient's current status is unknown at this time.
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Manufacturer Narrative
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(b)(4).Batch # r40m9d.Investigation summary: the analysis results confirmed that thirteen lt200 cartridges were received sterile and with no apparent damage.The samples were opened and the cartridges were tested for functionality with a test device.Upon functional testing of the reloads, the device loaded, retained, and deployed 6 clips as intended.The clips were formed as intended and conforming to our manufacturing requirements.The event described could not be confirmed as the clips performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.
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Search Alerts/Recalls
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