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Model Number CA500 |
Device Problems
Difficult to Remove (1528); Dent in Material (2526)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2015 |
Event Type
malfunction
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Event Description
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Lap chole- "dr.(b)(6) was using the epix universal clip applier on a lap chole and once placed on the duct, he pulled the handle and it would not release.After a while, he was able to get the device removed.He examined it and believe there is a dent on the shaft.They opened up another and the second one was dented on the shaft as well, do they did not use it." patient status- "n/a".
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Manufacturer Narrative
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Ra has 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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Manufacturer Narrative
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Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed minor dents along the shaft of the returned unit.The dents along the shaft likely occurred 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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
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Search Alerts/Recalls
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