MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT; SEMI-RIGID SCOPE

Model Number	27011L
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Excessive Tear Production (2235); Patient Problem/Medical Problem (2688)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We evaluated the subject semi-rigid ureteroscope and we found the distal end is a little rough from long uses.Scopes shaft is bent and with approximately 60% broken light fibers.The seni-rigid ureteroscope was in use for approximately 12 years, purchased (b)(6) 2007.
Event or Problem Description
Ureteroscope was placed into ureter and advanced toward the kidney.During removal, the ureter stuck to scope and was avulsed.The ureter could not be repaired and a nephrectomy was performed.

• Brand Name: SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT
• Common Device Name: SEMI-RIGID SCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8379098
• Report Number: 9610617-2019-00021
• Device Sequence Number: 3013625
• Product Code: FGB
• UDI-Device Identifier: 04048551231371
• UDI-Public: 4048551231371
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K940464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: 27011L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 127