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 06/26/2020 |
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 transurethral resection in saline (turis) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved at the end of the procedure.The intended procedure was completed using another 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.Therefore, the evaluation was performed exclusively on the basis of the available information.According to the photos provided, it could be confirmed that the loop wire at the distal end of the resection electrode is broken and the ends of the wire have melted into balls.Furthermore, the insulation shows distinct signs of thermal damage.This type of damage is typical for an unintended contact with other metal parts, e.G.Surgical instruments.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.Therefore, this event/incident was attributed to use error.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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