OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24-28 FR., 0.2 WIRE, MEDIUM, 45° ANGLED; HF-RESECTION ELECTRODES
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Model Number WA22332D |
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 08/24/2018 |
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 an unspecified hysteroscopy procedure, a part of the loop wire at the distal end of the hf resection electrode broke off and a fragment fell inside the patient's body and remained there, since it could not be located.No further information was provided and there was also no report about an adverse event or patient injury.
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the loop wire at distal end of the hf resection electrode has broken off.The loop and the insulated area of the fork show distinct signs of thermal damage.This type of damage is typical for an unintended contact with other metal parts, e.G.Surgical instruments.If this happens, the current will not flow through the loop but through the scope and destroy the electrode.Therefore, this event/incident was classified as use error.Furthermore, 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 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.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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