DEPUY MITEK LLC US VAPR S90 4.0MM W/INTEGR HDP -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
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Catalog Number 225370 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Udi: (b)(4).A manufacturing record evaluation was performed for the finished device [u1812085] number, and no non-conformances were identified.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported by the affiliate in (b)(6) that during an arcr arthroscopic rotator cuff repair, it was observed that vapr s90 4.0mm w/integr hdp -ea device was not able to ablate nor coagulate.The procedure was completed with a replacement of the device.No surgical delay or patient consequence reported.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of 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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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number [u1812085], and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.Device history lot = > a manufacturing record evaluation was performed for the finished device lot number [u1812085], and no non-conformances were identified.
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