OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; LAPAROSCOPE, GYNECOLOGIC
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Model Number WA50042A |
Device Problems
No Display/Image (1183); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the charged couple device was damaged causing the purple image and green stripe and the e111 fog-free error.No other issues were found at evaluation.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable had a purple image.The issue was found during preparation for use.There were no reports of patient harm.
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Search Alerts/Recalls
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