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Catalog Number M-4D-G1 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number and the device manufacture date were unknown.Therefore, udi: (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 observed that the cutter device was bent.It was unknown if there were delays to the surgical procedure.A spare device was used to complete the procedure successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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The lot number and device manufacture date were reported as unknown in the initial medwatch report, the lot number has been updated to k3731188448 and the date of manufacture has been updated to nov.18, 2016.The unique identifier (udi) has been updated accordingly.Additional information: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed and assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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