OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A22041A |
Device Problems
Break (1069); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device has not yet been returned to the manufacturer 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 (turb) procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient.However, the fragments were retrieved.No further information was provided but 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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The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the ceramic insulation at the distal end of the resection sheath is damaged.A fragment is broken off.However, no parts are missing.In addition, there are clearly visible burn marks on the cutting edge and the inner and/or outer surface of the ceramic insulation.The cause of this damage and the breakage of the ceramic insulation is continuous thermal overload.Therefore, this event/incident was attributed to use error.Furthermore, 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 with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.In addition, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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