The device in question was not returned to medline renewal, however an unused, reprocessed har36m from the same lot that was still sealed in the original medline renewal package was returned for evaluation.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).During the investigation, the device was subjected to all inspection and testing procedures, and as a result, met all acceptance criteria.In addition, our review of the dhr reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The reported issue could not be confirmed at this time.The customer confirmed that no adverse patient consequence or additional medical intervention was required as a result of the incident.However, due to the reported delay in the procedure to obtain a new device, medline renewal is filing this medwatch report.H3 other text : another device from same lot evaluated.
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Medline renewal received a report indicating that a reprocessed ethicon harmonic ace+ laparoscopic shears without adaptive tissue technology, model har36m, did not connect properly to the generator, and that the device would not activate during use.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.
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