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 05/02/2019 |
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 transcervical resection of the endometrium in saline (tcris) procedure, the loop wire at the distal end of the hf resection electrode melted, detached and fell into the patient¿s uterus.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided 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 evaluation was exclusively performed on the basis of the provided information.According to the available documentation, the loop wire at the distal end of the hf resection electrode melted, detached and fell into the patient¿s uterus.Causal for this damage and the subsequent breakage/melting of the loop wire 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 manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production 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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