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Model Number 72202958S |
Device Problems
Crack (1135); No Display/Image (1183); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found distal tip damage, fiber damage, and a scratched and chipped 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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Event Description
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It was reported that the vas hd, ac, 4mm x 70 deg scope had no image.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had chipped 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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Search Alerts/Recalls
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