MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. VIPER; FIBER-URETERORENOSCOPE 9.6FR WL 680MM

Model Number	7325071
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been no report of injury to the patient.The reported issue did not cause any critical delay or pose any unacceptable risk.However, richard wolf medical instruments corp.(rwmic) has submitted a comparable reportable serious incident in the past two years and therefore have considered to report this case to be a reportable malfunction.
Event or Problem Description
It was reported that during a cystoscopy with laser lithotripsy, the coating at the tip of the scope is bunched up.

• Brand Name: VIPER
• Common Device Name: FIBER-URETERORENOSCOPE 9.6FR WL 680MM
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: philip umali ; 353 corporate woods parkway; vernon hills,, IL 60061 ; 8479131113
• MDR Report Key: 22507234
• Report Number: 1418479-2025-00006
• Device Sequence Number: 21148515
• Product Code: FAJ
• UDI-Device Identifier: 04055207013694
• UDI-Public: 04055207013694
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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
• Device Model Number: 7325071
• Device Catalogue Number: 7325.071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2018
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown