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
Detachment of Device or Device Component (2907)
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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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Manufacturer Narrative
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The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the ceramic tip was loose.The following non-reportable malfunctions were found during the device evaluation: the sealing ring was scratched.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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 a ceramic head loose.The issue was found during reprocessing.There were no reports of patient harm.
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Search Alerts/Recalls
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