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
Asystole (4442)
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Event Date 06/10/2020 |
Event Type
Injury
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Event Description
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Olympus was informed that during a therapeutic hysteroscopy and endometrectomy procedure, the loop wire at the distal end of the hf resection electrode broke off and a fragment fell into the patient.It is unknown whether or not the broken fragment was retrieved.According to the information provided to us by the hospital, the intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.However, the report submitted by the hospital to the french competent authority ansm also contains a reference to asystole, due to which the procedure had to be interrupted and the patient transferred to the cardiology department.This information is currently still being clarified.
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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 patient¿s outcome 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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Manufacturer Narrative
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Additional information: b5 - describe event or problem.Correction: h4 - device manufacturer date.Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer but the exact cause of the reported failure could not be conclusively determined.However, the reported electrode breakage is a known error phenomenon and can very likely be attributed to component failure caused by use-related wear and tear.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 cause of the reported asystole could not be determined and is also judged as unknown by the hospital.However, no causal relationship is seen between the asystole and the breakage of the hf electrode's loop wire.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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Event Description
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Olympus was informed that during a therapeutic hysteroscopy and endometrectomy procedure, the loop wire at the distal end of the hf resection electrode broke off and a fragment fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed using another similar device.However, the patient suffered an asystole and had to be transferred to the cardiology department but has reportedly recovered well.
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Search Alerts/Recalls
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