OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22306D |
Device Problems
Break (1069); Fracture (1260); 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 03/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for 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.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode 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.
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Event Description
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Olympus was informed that during a therapeutic hysteroscopic uterine myomectomy procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.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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Event Description
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Olympus was informed that during a therapeutic hysteroscopic uterine myomectomy procedure, the loop wires of two hf resection electrodes from the same model and lot broke off and fell inside the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was successfully completed with a third hf resection electrode and there was no report about an adverse event or patient injury.
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Search Alerts/Recalls
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