OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; THORACOSCOPE SYSTEM
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Model Number WA53000A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2023 |
Event Type
malfunction
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Event Description
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The customer reported that a telescope, 10 mm, 0°, hd, quick lock, autoclavable¿s light guide connector was loose and came off.The event occurred after the procedure.The therapeutic procedure (total laparoscopic hysterectomy) was completed with the same device.There was no patient harm associated with the event.
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation (loose light guide connector and comes off) was confirmed.In addition, there was foreign matter adhesion on the internal lens.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.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, it is likely that the event occurred due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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