OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE,
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Model Number WA22302D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bowel Perforation (2668)
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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, patient's outcome 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 transvaginal uterine fibroid resection procedure at an unknown date around 2018, it is suspected that the patient has suffered an intestinal injury although the muscle layer was scraped and no obvious perforation was made.The intended procedure was completed with an intervention procedure on the next day when the injury of the intestine was sutured.No further information was provided and there was no report of malfunction for any of the olympus medical devices.
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.There were no reports of any malfunction of the hf-resection electrode.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.Furthermore, a dhr 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.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.However, 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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Search Alerts/Recalls
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