OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A42011A |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/12/2020 |
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 hysteroscopy procedure, the ceramic insulation at the distal end of the resection sheath broke off inside the uterus.The uterine cavity was thoroughly rinsed and two fragments were recovered.The intended procedure was successfully completed with 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 returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that part of the ceramic insulation at the distal end of the resection sheath is broken off and is missing.In addition, there are scratches and dents visible on the resection sheath.The type of damage found is typically caused by thermo-mechanical fatigue and/or mechanical overload, possibly as a result of excessive force.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged or worn before the incident, whether the damage was triggered during the last reprocessing cycle preceding the incident, or during the actual 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 resection sheath without showing any abnormalities.The case will be closed from olympus side but, independently from the above mentioned issue, a capa was initiated in march 2019 where further investigations, trending, and surveillance will be performed and the user will be informed about the investigation results.
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