OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTOSCOPE SHEATH
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Model Number A42011A |
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 12/03/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus that the resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs ceramic tip was loose.The event occurred during reprocessing.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 was confirmed.There were no additional findings.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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Search Alerts/Recalls
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