OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, LARGE, 24-28 FR., 12° AND 30°; HF-RESECTION ELECTRODES
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Model Number A22258A |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/20/2022 |
Event Type
Injury
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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 patient's outcome 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 transcervical resection (tcr) procedure, the ball at the distal end of the hf eectrode broke off an fell into the patient's uterus.The intended procedure was completed using the same set of equipment.An ultrasound examination was performed which confirmed that the fragment was still in the uterus.Upon the patient's request treatment is to be continued at another hospital.No further information was provided.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, although the subject device was not returned for an evaluation, the reported issue is likely due to wear and tear.This supplemental report includes a correction to a1, d9, e1, and g2 to provide information that was inadvertently not included in the initial medwatch.Also, new information has been added to d8.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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