Model Number 173016 |
Device Problems
Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
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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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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 laparoscopy, one device was difficult to toggle.Both of the devices failed, indicating that one needle fell off with one device and that the needle got stuck with the other device.
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Manufacturer Narrative
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Evaluation summary post market vigilance (pmv) led an evaluation of one device.The device had bent blades.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the bent blade indicates that the instrument may have been exposed to an external force which bent the exposed metal bars.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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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 laparoscopy, one device was difficult to toggle.Both of the devices failed, indicating that one needle fell off with one device and that the needle got stuck with the other device.No patient injury.
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Search Alerts/Recalls
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