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Catalog Number 530.620 |
Device Problems
Melted (1385); Overheating of Device (1437); Loss of Power (1475)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/22/2014 |
Event Type
malfunction
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Event Description
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This is report 2 of 2 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the battery reamer drill device overheated and stopped functioning.According to the reporter, the device was then switched off and on again.However, the device was still not functioning.The reporter indicated that the battery inside the casing was checked and it was found that part of the battery housing was melted.There were no delays to the planned surgical procedure as a spare device was available for use.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 report will be submitted accordingly.
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Manufacturer Narrative
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(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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the control unit was not functioning.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available; a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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