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 Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2018 |
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 a therapeutic cervical neoplasm resection procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.The loop wire was reportedly not retrieved but an examination by x-ray showed no foreign objects inside the patient.No further information was provided, but 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 the manufacturer for evaluation/investigation.Therefore, the evaluation was exclusively performed on the basis of the provided information.According to the available photo documentation, it could be confirmed that the broken loop wire at the distal end of the hf resection electrode was molten at both ends.The cause of this damage is most likely mechanical overload by the application of excessive force in combination with an unintended contact with other metal parts (e.G.Surgical instruments).Therefore, this event/incident was attributed to 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.The case will be closed from olympus side with no further actions but 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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