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); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/08/2021 |
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 uterine myomectomy procedure, when the surgeon tried to bent the tip of the electrode to better remove the fibroid.The entire electrode got detached and fell into the patient¿s body cavity.However, no fragments remained inside the patient since they were reportedly retrieved.No further information was provided but the intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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Additional information: d4 - lot number; h4 device manufacturer date device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-02-16).The evaluation at omsc confirmed that the loop wire at the distal end of the resection electrode is broken off due to mechanical stress.Furthermore, the electrode contact was found torn off due to removing the electrode from the working element by application of excessive force.Therefore, this event/incident was attributed to use error.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 on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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