OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BAND, 24 FR. 12 DEGREES, STE; STERILE, SINGLE-USE HF-RESECTION ELE
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Catalog Number A22221C |
Device Problem
Break (1069)
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Patient Problem
Twitching (2172)
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Event Date 05/01/2014 |
Event Type
malfunction
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Event Description
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Olympus was informed that during an unspecified transurethral resection (tur) procedure, the ceramic insulation of the resection sheath (a22041a) broke off inside the pt.No fragments/parts remained inside the ot as they were reportedly retrieved by unk approach.The intended procedure was reportedly completed by using a similar device.There was no report about an adverse event or pt harm or injury.However, it was reported that the pt's legs were repeatedly twitching due to the unintended stimulation of the obturator nerve.Furthermore, an identical product problem/malfunction reportedly occurred again with a resection sheath of the same model (a22041a) but from a different lot during another subsequent procedure.However, no other info was provided for the second incident.
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Manufacturer Narrative
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The suspected medical devices were not yet returned to the mfr for eval/investigation.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judges as unk.However, if the suspect medical devices are returned for eval or add'l significant info becomes available, this report will be updated.This report refers to the suspect medical device labeled as a22221c in the initial report about the same incident.Cross-reference to/duplicate of mfr report # 9610773-2014-00016, 9610773-2014-00017, 9610773-2014-00018.Olympus submits this incident as a medical device report (mdr) in abundance of caution.
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Search Alerts/Recalls
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