Catalog Number 03.000.395 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported that the cutter device had developed a crack.It was reported that this event did not occur during surgery.It was not reported if there were any delays to a surgical procedure or whether a spare device was available for use.There was no human patient involvement as this was a veterinary procedure.The exact date of this event was unknown.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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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 device had a crack in/on the left side of the blade approximately 15mm distally of the weld and approximately 11mm long.It was also observed that both sides of the blade were also observed to have abnormal bends at the edges approximately 21mm distally of the weld.It was noted that the damage to the blade appears to have been caused by abnormal use (excessive force) of the device.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to excessive force which is user error.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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Search Alerts/Recalls
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