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Model Number 012001 |
Device Problems
Failure to Cut (2587); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopic living donor nephrectomy procedure, noise was heard while in use, and tissue was not cut.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument registered a mechanical fault.The instrument was disassembled; a crack was noticed in the proximal portion of the probe shaft.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cracked probe shaft may occur when the probe shaft makes contact with the outer tube while the system was energized.The information for use for this product states, avoid using the device as a lever, either while dissecting or while activating the instrument.Added stress to the tip may cause the probe to touch in the inner tube portion of the instrument, resulting in mechanical failure and/or rendering the instrument inoperable.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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