Catalog Number 284002 |
Device Problem
Unknown (for use when the device problem is not known) (2204)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/09/2014 |
Event Type
malfunction
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Event Description
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It was reported by the sales rep that during a rotator cuff repair they noticed a decreasing visibility through a smith and nephew scope.Customer was able to complete the procedure using the pump.No patient consequences.Device to be returned.This pump was used in three different procedures and had issues during all three.See associated medwatch # 1221934-2014-00418, 1221934-2014-00419.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
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Manufacturer Narrative
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The customer¿s complaint could not be duplicated and no fault was found on this pump.The device passed all tests.Furthermore, there were no other complaints reported on this serial number.At this point in time, no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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It was reported by the sales rep that during a rotator cuff repair they noticed a decreasing visibility through a smith and nephew scope.Customer was able to complete the procedure using the pump.No patient consequences.Device to be returned.This pump was used in three different procedures and had issues during all three.See associated medwatch # 1221934-2014-00418, 1221934-2014-00419.
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Search Alerts/Recalls
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