OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22306D |
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 12/12/2018 |
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 of the prostate (turp) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided, but 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 returned to the manufacturer for investigation.The investigation confirmed that the loop wire at the distal end of the hf-resection electrode has broken off at both ends of the fork.Furthermore, the insulation (the blue and yellow tubes as well as the ceramics tubes) show thermal damage.The metal at one of the ends of the fork shows traces of molten material.The cause of this damage is most likely an unintended contact with other metal parts, e.G.Surgical instruments.Therefore, this event/incident was attributed to use error.Furthermore, 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 from olympus side with no further actions but the reported event/incident 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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