OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; OES THORACOSCOPE SYSTEM
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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 that the telescope, 10 mm, 0°, high definition, quick lock, autoclavable was damaged by dropping.The event occurred during a therapeutic laparoscopic procedure, and it was completed with a similar device.There was no procedural delay, or no patient harm associated with the event.The device was returned and evaluated, and upon estimation it was observed that the eyepiece was damaged (drop damage).This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation was confirmed due to damage to the eyepiece.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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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 determined.It is likely the reported event 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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Search Alerts/Recalls
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