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Catalog Number SHORT |
Device Problems
Difficult To Position (1467); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/27/2017 |
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 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 from (b)(6) that during an unspecified surgical procedure, it was discovered that the attachment device internal jack was deformed which he consumptive material could not be inserted into the device smoothly.It was unknown if there were any delays to the planned surgical procedure.A spare device was available for use.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 was returned for evaluation.Reliability engineering evaluated the device and observed that the device bearings were damaged, the ball bearings came apart, the balls and cage were missing and the extension sleeve was damaged.It was also noted that the device failed the following pre-tests: lock operation, cutter insertion and temperature.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to construction/design issues.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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Correction: the date returned to manufacturer was documented as jun 15, 2017 in the initial report and has been updated as jul 6, 2017.Further evaluation determined that the assignable root cause was not due to construction/design issues but wear from normal use and servicing over time.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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