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 Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 01/26/2021 |
Event Type
Injury
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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 resection of fibroid procedure the loops at the distal end of two hf resection electrodes broke and fragments fell into the patient¿s body cavity.X-ray examinations were performed of the patient, the resected tissue, and the suction fluid but the broken fragments could not be located.The intended procedure was prolonged by about 30 minutes but then completed using a similar device 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 devices were not returned to the manufacturer for evaluation/investigation.Instead, nine unused electrodes of the same lot number were returned.For these nine electrodes, no deviations from the specifications were detected.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 electrodes without showing any abnormalities.Based on the information available, the application problems, more specifically the lack of energy to the loop and the premature wear of the electrodes, were most likely caused by the use of bipolar electrodes in a monopolar application.Therefore, this event/incident was attributed to use error.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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Manufacturer Narrative
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Manufacturer narrative: according to fda-air received on nov.23, 2022 this report is to be resubmitted as serious event.The additional x-ray and the fact that fragments may remained inside the patient was re-assessed as a serious injury.All other submitted information remain valid.
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Search Alerts/Recalls
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