MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA VISION; SENSOR-URETERORENOSCOPE 9.9FR WL 680MM

Model Number	7356071
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the device broke when the physician was trying to advance the flexible working channel into the patient's narrow ureteral orifice.Due to the narrowed ureter, the primary and the backup device could not be used.Also, since doctor could not get any access to the urine output (uo), the scheduled procedure was not completed and needed to be rescheduled.There was no patient harm reported.

• Brand Name: COBRA VISION
• Common Device Name: SENSOR-URETERORENOSCOPE 9.9FR WL 680MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21688532
• Report Number: 9611102-2025-00017
• Device Sequence Number: 21026214
• Product Code: FGB
• UDI-Device Identifier: 04055207054864
• UDI-Public: 04055207054864
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: Other
• Device Model Number: 7356071
• Device Catalogue Number: 7356071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown