OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22507D |
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 01/23/2020 |
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 therapeutic hysterectomy procedure, the loop wire at the distal end of the hf-resection electrode broke off and fell into the patient¿s uterus.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided.
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the loop wire at the distal end of the hf resection electrode is broken and that one wire end has melted into a ball.Furthermore, the wire insulation shows signs of thermal damage.The damage to the distal end of the electrode was caused by excessive force and/or wear and tear and thus can be attributed to use error.Also, 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 on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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