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Model Number CA500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
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Event Description
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Procedure performed: lap chole.Account manager was not present in any of the cases.The surgeon for all 3 lap chole cases.1 occurred on (b)(6) and 2 occurred on (b)(6), all were from the same lot number, 1326493.According to account manager, the surgeon has used the applied clip applier extensively since it was re-introduced and hasn't experienced any issues until now.The same event description was given for all 3 events.While firing the clip onto the duct, the tip of the clip would not close.The trigger was squeezed plastic to plastic.They were able to finish the procedure with the same clip applier.Doesn't know if the clip was fully loaded into the jaws upon actuation.Doesn't know if the vessel was fully skeletonized prior to using the clip applier, but account manager said that he has been in many cases with surgeon and he has always skeletonized before using the clip applier in those prior cases.There was no harm to the patient.Devices were already discarded.
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Manufacturer Narrative
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Investigation summary: the event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
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Event Description
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Procedure performed: lap chole.Account manager was not present in any of the cases.The surgeon for all 3 lap chole cases.1 occurred on nov 19 and 2 occurred on nov 26, all were from the same lot number, 1326493.According to account manager, the surgeon has used the applied clip applier extensively since it was re-introduced and hasn't experienced any issues until now.The same event description was given for all 3 events.While firing the clip onto the duct, the tip of the clip would not close.The trigger was squeezed plastic to plastic.They were able to finish the procedure with the same clip applier.Doesn't know if the clip was fully loaded into the jaws upon actuation.Doesn't know if the vessel was fully skeletonized prior to using the clip applier, but account manager said that he has been in many cases with surgeon and he has always skeletonized before using the clip applier in those prior cases.There was no harm to the patient.Devices were already discarded.Patient status: no harm to the patient.
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Search Alerts/Recalls
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