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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swelling (2091); Stenosis (2263)
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Event Date 11/24/2020 |
Event Type
Injury
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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 patient's outcome 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 follow-up appointment after a successfully completed therapeutic transurethral resection of the prostate (turp) procedure, it was found that the capacity of the patient's bladder was very small and that the patient had developed peri-urethral swelling and a stricture.There were no reports of any device malfunctions during the initial procedure.
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Manufacturer Narrative
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Device evaluation: 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 patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, there were no reports of any damage to the electrode or any other adverse event during the procedure.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-electrode without showing any abnormalities.Thus, there is no indication for a causal relationship between the electrode and the reported post-operative complications.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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