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Catalog Number EL5ML |
Device Problems
Failure to Form Staple (2579); Activation, Positioning or Separation Problem (2906); Ejection Problem (4009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/12/2019 |
Event Type
malfunction
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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 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.
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Event Description
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It was reported that during a right thoracotomy, the doctor was trying to ligate peripheral vessels and encountered the following issues with the clip applier.Clips were scissoring, clips were falling out of the device, and clips were not deploying.The doctor continued to use device to complete the procedure.There were no patient consequences reported.
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Manufacturer Narrative
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(b)(4).Batch # p9259v.Investigation summary: the analysis results found that the el5ml device was returned with no damage in the external components.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 6 conforming clips.Upon testing, the jaws opened and closed without any difficulties.In addition, the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.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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