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Model Number 176630 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Post market vigilance (pmv) led an evaluation of one endo clip iii clip applier.The clip applier was received partially applied.No visual abnormalities were observed.Functionally, the clip applier was cycled but the clip did not load.The pusher bar was observed to not be functioning properly.A review of the device history record for the clip applier indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The trip lever out of position preventing the clips from loading properly.A process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopy, there were no clips in the product, the device did not fire any clip.A new instrument was used to resolve the issue.There was no patient injury.
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Search Alerts/Recalls
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