OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22302D |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device has not yet been returned to olympus 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 therapeutical resection of submucosal myoma of the uterus procedure, after the electrode had been used for about 30 minutes, the loop wire at the distal end of the hf electrode broke off and fell into the patient.However, no fragments remained inside the patient since they were reportedly rinsed out with irrigation fluid, which was additionally confirmed by an x-ray examination performed after the surgery.The intended procedure was completed using 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 not returned to the manufacturer 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 conclusively determined and is being judged as unknown.However, based on the customer's description and our experience, the reported damage was most likely caused by use-related wear and tear.A dhr review could not be performed since basic data of article identification (lot number) is missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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Search Alerts/Recalls
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