Model Number 72202961S |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that the scope was cracked.No case involved.Therefore, there was no patient involved.Results of investigation have shown the scope had a cracked distal lens which makes it a reportable event.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 reported device, intended for use in treatment, there was a relationship found between the returned device and the reported incident.A visual inspection found distal tip and fiber damage and cracked distal lens.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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