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Catalog Number 72202087S |
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 11/05/2019 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure, the device had a quality issues.No backup device was available.No delay and no patient injuries were reported.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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Updated information.The device, used in a procedure, was returned for evaluation.The evaluation was performed by the supplier and could confirm the customer complaint for the device has quality issues.A visual inspection was performed and showed the scope to have a bent outertube and broken lenses.This damage is caused by contact with another source.Documentation, related to the device history and complaint history, was reviewed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Search Alerts/Recalls
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