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	12/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a ureteroscopy with holmium laser lithotripsy procedure, the doctor was unable to feed the laser fiber through the scope.The doctor removed the laser fiber from scope to re-feed the guidewire back up into the kidney.These steps were repeated unsuccessfully and caused a delay of approximately 30 minutes.Due to the difficulty of inserting the laser fiber into the scope, the doctor decided to performed a stent to the patient.Although the surgical procedure was unable to be completed, there is no report of injury or illness to the patient.
Additional Manufacturer Narrative
Correction: section b.Adverse event or product problem.No.2: outcomes attributed to adverse event.Option: life-threatening.The option, "life-threatening", was mistakenly selected when initially submitted.The reported issue is not under a life threatening situation.Therefore the selection for the said option is now unchecked.

• Brand Name: BOA VISION
• Common Device Name: SENSOR-URETERORENOSCOPE 8.7FR WL 680MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 24135028
• Report Number: 1418479-2026-00001
• Device Sequence Number: 16038211
• Product Code: FGB
• UDI-Device Identifier: 04055207054840
• UDI-Public: 04055207054840
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 7355071
• Device Catalogue Number: 7355071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2026
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/21/2026
• 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: Life Threatening; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/21/2026