Model Number 11272C1 |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
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Event Date 01/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Customer has not returned product 11272c1 serial number (b)(4) for further review or to verify part #.Per our records, this serial number was assigned to #11272ck2 on (b)(6) 2012.Our records show, this facility purchased #11272ck1 serial number (b)(4), on (b)(6) 2012, on sales order 187994245, outbound #82500942.The customer has not responded to our attempts to confirm or if they are returning the product.The instrument has not been returned for services since (b)(6) 2012.Item 11272c1 has been discontinued, on (b)(6) 2018, and replaced by #11272ck2.
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Event Description
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Per the customer, during a elective left percutaneous nephrolithotomy, left nephrostomy tube insertion, and left nephrostogram procedure, the left renal calculus was extracted successfully utilizing the flexible nephroscope, and the left nephrostogram demonstrates no extravasation.Surgeon observed black particle during the procedure, realized that it came from the end of the flexible cystoscope.They were able to retrieve it and the piece matched the end of the flexible cystoscope.Instrument had broken pieces of coating on the tip of the scope.The scrub tech, the surgeon and the rn in the case examined the scope and decided that all pieces had been retrieved.The patient tolerated the procedure, and was then transferred to a post-anesthesia care unit.Patient was stable and was then discharged home.
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Search Alerts/Recalls
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