OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE
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Model Number WA53000A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported to olympus, the 10mm rigid telescope, hd, quick lock, was producing a blurry or foggy image.Inspection and testing of the returned device found the eyepiece was damaged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation.But the customer's allegation could not be confirmed.Additionally, the device evaluation found signs of damage and corrosion of the outer tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be conclusively determined.It is likely the reported event (damaged eyepiece) occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.
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