DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
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Catalog Number 519.530 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location is unknown.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the hose of the device ruptured.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to environment conditions.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the hose device ruptured.It was further determined that the device failed pretest for general condition and check outer hose.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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