UMKIRCH DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 519.530 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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This is report 4 of 4 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure,it was observed that four air hose devices were leaking.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available to complete the procedure.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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