OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; ELECTRODES, ELECTROSURGICAL
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Model Number WA47787A |
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 05/12/2021 |
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 of the fibroids (tcrf) procedure, the loop wire at the distal end of the electrode broke and a fragment fell into the patient.The broken-off fragment could not be retrieved as it was too small to be visible via x-ray.A follow-up procedure was scheduled in one month to complete the procedure.The patient is reportedly fine.
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Manufacturer Narrative
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Additional information: h4 ¿ device manufacturer date.Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the loop wire at the distal end of the hf electrode is broken off due to brittle failure.Thus, the reported event/incident was attributed to component failure.This is a known error pattern, which has already been examined in the past.However, it was assessed that a material change was not required based on the very low number of occurrences of this failure mode.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 on olympus side with no further actions.However, the reported phenomenon 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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