OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 30°, WITH TROCAR
TUBE CONNECTOR; ULTRA TELESCOPES
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Model Number WA4KA430 |
Device Problem
Melted (1385)
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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 when using a telescope ultra¿, 4 mm, 30°, with trocar tube connector, there was melting at the tip.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 (melting at the tip) was confirmed.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.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.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 reported event is unable to be determined.However, the cause of the event is likely due to wear and tear and insufficient or inadequate reprocessing.Olympus will continue to monitor field performance for this device.
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