OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22302D |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, the reported failure is a known phenomenon usually caused by wear and tear.The loop wire at the distal end of the hf electrode may wear out during use and may break, burn or melt.Thus, this incident can most likely be attributed to user error.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.However, the reported event/incident will be recorded for trending and surveillance purposes.
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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 into the patient's urethral prostate tissue.Due to the lack of a sheath and grasping forceps, the surgeon used a new hf loop resection electrode to remove the broken fragment and flush with a lot of rinsing fluid.However, the loop wire disappeared from the field of vision.The other doctors searched outside the body, and the chief surgeon repeatedly searched for broken parts in the surgical cavity but could not locate the fragment.An x-ray examination was performed but no fragments could be located.Since no abnormalities were identified during x-ray, it was assumed that the fragment was flushed out of the patient¿s body.No patient injury was reported.
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