OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; LAPAROSCOPE
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Model Number WA53005A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2023 |
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 device evaluation found loosening of the light guide connector, an outer tube dent, and scratches on the eyepiece.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported to olympus, the telescope, had a disconnected light guide connection.The issue was found during inspection for use for a therapeutic, thoracoscopic surgery.The procedure was completed using a similar device.There were no reports of patient harm.
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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.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 of the event was unable to be identified.The event likely occurred due to user error, improper handling and application of excessive force like fall or shock.Olympus will continue to monitor field performance for this device.
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