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Catalog Number 72202087 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, the device was not working.No delay or patient injuries were reported.No backup was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the device was not working.A visual inspection was performed and showed the scope to have distal tip damage, a bent outertube and broken lenses.This damage is caused by contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
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Search Alerts/Recalls
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