MAUDE Adverse Event Report: RICHARD WOLF GMBH BOA VISION; SENSOR-URETERORENOSCOPE 8.7FR WL 680MM

Model Number	7355071
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no injuries or unacceptable risks to the patient were reported, (b)(6) considers this case a "reportable malfunction" due to a similar incident being reported as a "serious injury" in the past two years.
Event or Problem Description
It was reported that during a procedure, the customer complained that the screen went black and the brush could not be pushed through the endoscope.However, the scheduled procedure was completed after a 10-minute delay using a backup device.No injuries or unacceptable risks were reported.

• Brand Name: BOA VISION
• Common Device Name: SENSOR-URETERORENOSCOPE 8.7FR 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: 25096721
• Report Number: 9611102-2026-00018
• Device Sequence Number: 18639615
• Product Code: FGB
• UDI-Device Identifier: 04055207054840
• UDI-Public: 04055207054840
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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
• Device Model Number: 7355071
• Device Catalogue Number: 7355071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown