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); Material Fragmentation (1261); Mechanical Problem (1384); 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 12/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, it was reported that the single-use hf resection electrode had probably been reprocessed and reused on the patient.The case will be closed from olympus side but may be reopened if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.
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Event Description
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Olympus was informed that during an unspecified therapeutic transurethral resection (tur) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.It is unknown if all fragments could be retrieved.No further information was provided but the intended procedure was successfully completed with a similar set of equipment and there was no report about an adverse event or patient injury.
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Search Alerts/Recalls
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