MAUDE Adverse Event Report: KARL STORZ ENDOVISION CYSTO-URETHRO-FIBERSCOPE; FLEXIBLE URETHROSCOPE

Model Number	11272C1
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Common Device Name: FLEXIBLE URETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 9152668
• Report Number: 1221826-2019-00088
• Device Sequence Number: 11295737
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K945185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11272C1
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR