(b)(4).Device manufacture date: the device manufacture date is unavailable reporter¿s phone number: (b)(6).The manufacturing location is currently not available.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported from by (b)(6) that the compact air drive device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the reverse locking mechanism was blocked and the gear was worn out.It was further determined that the device failed for general condition, check for air leak, check function of soft mode switch (safety system), check triggers for forward/reverse mode and for check for excessive noise.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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