OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A22040A |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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Event Description
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Olympus was informed that during a therapeutic transurethral resection of the bladder (tur-b) procedure, the ceramic insulation at the distal end of the inner sheath broke off and fell into the patient's bladder.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was extended by approx.20 minutes due to the retrieval of the fragments.However, the procedure was successfully completed using a similar device and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2020-12-02).The evaluation/investigation confirmed that the ceramic insulation at the distal end of the inner sheath is broken off.This type of damage is typically caused by thermal and/or mechanical overload in combination with wear and tear.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged before the incident occurred, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the last procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the inner sheath without showing any abnormalities.The case will be closed on olympus side and the user will be informed about the investigation results.Furthermore, independently from the above mentioned issue, a capa was initiated in march 2019 where further investigations, trending, and surveillance will be performed.
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