OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12; HF-RESECTION ELECTRODES
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Model Number A22201A |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/18/2020 |
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 transcervical resection (tcr) procedure, sparks occurred during coagulation and it was then noticed that the loop wire at the distal end of the hf resection electrode had broke off and fallen into the patient.An x-ray examination was performed but the broken off fragment could not be located.No further information was provided but the intended procedure was completed with the same set of equipment and 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 not returned to olympus for evaluation/investigation.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, based on the customer's description and our experience, the reported damage can most likely be attributed to use-related wear and tear.Since the user facility could not definitely determine the lot number of the relevant hf resection electrode, a manufacturing and quality control review was performed for all possible lot numbers (lot #: 13303p03l001, device manufacturer date: 05.11.2013; lot #: 14057p03l003, device manufacturer date: 11.03.2014; lot #: 14058p03l001, device manufacturer date: 07.03.2014) of the resection electrode without showing any abnormalities related to function and safety.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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