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
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
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 had poor tube sheath.There was no delay, and the patient was not under anesthesia.There was no patient harm associated with the event.The device was evaluated, and it was found that the ceramic tip had cracks.This mdr (medical device report) 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.In addition to the ceramic tip having cracks 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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