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); Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/06/2016 |
Event Type
Injury
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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.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, 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 related to function and safety.The case will be closed from olympus side with no further actions, but the reported phenomenon will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during a transcervical resection of the endometrium in saline (tcris) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.No further information was provided but the intended procedure was reportedly extended and a follow-up procedure was performed.
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Search Alerts/Recalls
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