OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°; HF-RESECTION ELECTRODES
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Model Number A22251A |
Device Problems
Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the roller at the distal end of the hf resection electrode detached and fell inside the patient.The roller was reportedly not retrieved but an examination by x-ray showed no foreign objects inside the patient.The intended procedure was successfully completed with another hf resection electrode and there was no report about an adverse event or patient injury.
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