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Model Number CA500 |
Device Problems
Dent in Material (2526); Misfire (2532)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/16/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: six (6) sterile units were returned for evaluation.Upon inspection, engineering tested one of the returned samples.There were dents along the shafts.Engineering actuated, the clips loaded and closed properly.Although the root cause of the damaged shaft cannot be determined, the dent on the shaft likely happened while removing the device from the tray packaging.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.As a part of this process, applied medical is currently investigating packaging enhancements intended to further minimize the potential for this type of incident to occur.This document represents our final report.
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Event Description
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Cholecystectomy- "clip appliers described as having 'dents in the shaft and tip of the clip applier, causing the clips to misfire." patient status: ok.
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Manufacturer Narrative
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(b)(4) has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
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Search Alerts/Recalls
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