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

Model Number	7355071
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility representative reported that sensor-ureterorenoscope 8.7fr wl 680mm, part no.7355071, serial no.(b)(4), deflection cover bunched up and the surgeon could not pull the scope through the access sheath and ureter.The primary surgeon needed to call a partner who was able to help remove the scope.The secondary urology (the specialist) didn't seem upset about the issues.I am not sure why the deflection cover bunched up.Additional information was received from the user facility representative on january 20, 2023.According to the received information, there was a delay of 45 minutes in the procedure and a follow-up procedure is necessary to complete the scheduled and planned treatment.

• 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 ; GM
• MDR Report Key: 16385091
• Report Number: 1418479-2023-00001
• Device Sequence Number: 12033773
• Product Code: FGB
• UDI-Device Identifier: 04055207054840
• UDI-Public: 04055207054840
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023
• Report Date (Section F): 02/15/2023

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: 7355071
• Device Catalogue Number: 7355071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/20/2023
• Device Age: 32 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/15/2023