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Model Number 7205682 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported device, used 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, the needle is dented, deep scratch on the negative lens and a loose system. 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 scope was found with the distal tip of the lens cracked/scratched when the sales rep picked up the tray from an account.The incident occurred after the procedure; therefore, there was no patient involvement.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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