DEPUY SYNTHES PRODUCTS LLC DOUBLESPIR-AIR-HOSE L2M F/SYST-SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
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Catalog Number 519.550 |
Device Problem
Air Leak (1008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: gtin is unavailable as the product made prior to compliance date.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the air hose device had an air leak.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.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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