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 Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2017-10-13).However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are available, this report will be updated.
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Event Description
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Olympus was informed that during cleaning, after an unspecified therapeutic transurethral resection (tur) procedure, it was noticed that the ceramic insulation at the distal end of the inner sheath had broken off and was missing.It is unknown when this damage occurred and whether a fragment fell inside the patient's bladder.However, the tur was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.In addition, the user facility considers performing a ct to confirm that no foreign objects remained inside the patient.
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Manufacturer Narrative
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Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2017-10-11).The evaluation/investigation confirmed that the ceramic insulation at the distal end of the inner sheath had broken off.The cause of this damage and the breakage of the ceramic insulation is most likely excessive high-frequency output power and mechanical overload in combination with improper handling.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 inner sheath without showing any abnormalities.It is clearly stated as a warning note in the instructions that impact, fall, shock or similar stress can damage the ceramic insulation 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 thermal and 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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Event Description
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A ct scan was performed which confirmed that no fragment remained inside the patient.
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Search Alerts/Recalls
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