OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE; HF-RESECTION ELECTRODES
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Catalog Number WA22301D |
Device Problems
Bent (1059); Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2015 |
Event Type
malfunction
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Event Description
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Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the user facility staff noticed a broken off and missing loop wire at the distal end of the hf resection electrode.It is unk when exactly this damage occurred and whether a fragment/part fell inside the pt.However, no pieces were found during search, under endoscopic view and by x-ray.Furthermore, it was reported that the operating surgeon accidentally activated the high-frequency output of the electrosurgical generator while the suspect medical device was being withdrawn from the resectoscope and thus was still located inside the resection sheath.The intended procedure was subsequently completed by using another hf resection electrode and there was no report about an adverse event or pt injury.
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Manufacturer Narrative
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The suspect medical device was not returned to the mfr for eval/investigation but to olympus medical systems corp.(omsc), (b)(4).The eval/investigation found the hf resection electrode with melted loop wire.However, no fragments could fall inside the pt as the platin-iridium wire has completely melted down at both fork tubes and thus no parts are actually missing.The present failure mode is typical for an unintended contact with other metal parts, e.G.Surgical instruments.Therefore this incident was classified as use error and the case will be closed from olympus side with no further actions.However, the incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.Olympus submits this incident as a medical device report (mdr) in abundance of caution.
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Search Alerts/Recalls
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