OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A22042A |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/13/2017 |
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 in saline (turis) procedure, the ceramic insulation at the distal end of the resection sheath broke and a fragment fell inside the patient's bladder.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with the same set of equipment 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), (b)(4).The evaluation/investigation confirmed that the ceramic insulation at the distal end of the resection sheath is damaged.A large fragment is broken off.However, no part is actually missing since the fragment was returned as well.The cause of this damage and the breakage of the ceramic insulation is wear and tear in combination with mechanical overload by the application of excessive force like impact, fall, shock or similar stress.It is clearly stated as a warning note in the instructions that impact, fall, shock or similar stress can damage the ceramicinsulation at the sheath's distal end and that the instrument must not be used if damaged since otherwise this can cause injuries to the patient and/or user.The user apparently did not follow these instructions since the damage and breakage of the ceramic insulation were caused by mechanical overload.Therefore, this event/incident was attributed to use error and the case will be closed from olympus side with no further actions.However, the event/incident 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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