It was reported that the scope image was not clear and had lines.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit 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.Relevant tests/laboratory data, including dates.
|
H10, h3,h6: 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 deep distal tip and fiber damage, a crack in the distal lens, and sidearm glass cone damage.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.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.
|