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
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
malfunction
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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 tip being broken additional findings were the adhesive joint of proximal components were loose and the sealing ring is missing.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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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 the fixing screw missing.There was no patient harm associated with the event.The device was evaluated, and it was found the tip was broken.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
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