Model Number 176645 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2018 |
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 gallbladder procedure, the jaw of the device was dislocated.There was no patient injury.
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Manufacturer Narrative
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Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.The jaw alignment of device was within specifications.Jaws were inspected under a microscope and no physical damage to the jaws was found.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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 gallbladder procedure, the jaw of the device was dislocated.The product was changed to resolve the issue on order to complete the case.There was no patient injury.
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Search Alerts/Recalls
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