OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE; HF-RESECTION ELECTRODES
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Catalog Number A22201A |
Device Problems
Break (1069); Sparking (2595)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/02/2015 |
Event Type
malfunction
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Event Description
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Olympus was informed that during an unspecified therapeutic transcervical resection (tcr) procedure, the loop wire of the suspect medical device sparked, broke off and fell inside the pt.However, no fragments/parts remained inside the pt as they were reportedly retrieved by unk approach.The intended procedure was subsequently completed by using another similar device.No other info was provided but there was no report about an adverse event or pt injury.
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Manufacturer Narrative
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The suspect medical device was not returned to the mfr for eval/investigation but to olympus medical systems corporation (omsc), (b)(4).The eval/investigation found the hf resection electrode with heavily deformed and twisted fork tubes.Furthermore, the loop wire is damaged/broken and also deformed.Causal for this damage and the subsequent breakage of the loop wire is mechanical overload by the application of excessive force.Therefore this incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.Olympus submits this incident as a medical device report (mdr) in abundance of caution.
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