VIPER 7325071Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207013694), received between Apr 27, 2017 and Jul 15, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CYSTOSCOPY WITH LASER LITHOTRIPSY, THE COATING AT THE TIP OF THE SCOPE IS BUNCHED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507234 ↗
• InjuryDec 5, 2023Difficult to Insert; Difficult to Insert

  THE USER FACILITY HAS INFORMED RICHARD MEDICAL INSTRUMENTS CORP. (RWMIC) OF AN ISSUE REGARDING A FIBER-URETERORENOSCOPE 9.6FR WL 680MM, PART ID: 7325.071, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE PHYSICIAN WAS HANDED THE SCOPE, HE INSPECTED IT AND NOTICED THAT THE TIP APPEARED LARGER "LIKE A PIECE OF TAPE WAS PLACED ON IT DURING REPAIR, AND IT WILL NOT FIT INTO THE ACCESS SHEATH IF I WAS TO TRY IT". SCOPE WAS NOT USED AND WAS TAKEN OUT OF CIRCULATION IMMEDIATELY. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 5 MINUTE DELAY IN THE MIDDLE OF A CYSTOSCOPY, URETEROSCOPE, LASER LITHO AND STENT EXCHANGE PROCEDURE WHEN THE PHYSICIAN IDENTIFIED THE REPORTED ISSUE AND INSPECTED THE SCOPE. THE PHYSICIAN ELECTED NOT TO USE THE DEVICE. AS A RESULT, THE SCHEDULED PROCEDURE WAS NOT COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 18267698 ↗
• InjuryDec 5, 2023Difficult to Insert; Difficult to Insert

  THE USER FACILITY HAS INFORMED RICHARD MEDICAL INSTRUMENTS CORP. (RWMIC) OF AN ISSUE REGARDING A FIBER-URETERORENOSCOPE 9.6FR WL 680MM, PART ID: 7325.071, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE PHYSICIAN WAS HANDED THE SCOPE, HE INSPECTED IT AND NOTICED THAT THE TIP APPEARED LARGER "LIKE A PIECE OF TAPE WAS PLACED ON IT DURING REPAIR, AND IT WILL NOT FIT INTO THE ACCESS SHEATH IF I WAS TO TRY IT". SCOPE WAS NOT USED AND WAS TAKEN OUT OF CIRCULATION IMMEDIATELY. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 5 MINUTE DELAY IN THE MIDDLE OF A CYSTOSCOPY, URETEROSCOPE, LASER LITHO AND STENT EXCHANGE PROCEDURE WHEN THE PHYSICIAN IDENTIFIED THE REPORTED ISSUE AND INSPECTED THE SCOPE. THE PHYSICIAN ELECTED NOT TO USE THE DEVICE. AS A RESULT, THE SCHEDULED PROCEDURE WAS NOT COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 18266994 ↗
• MalfunctionNov 12, 2020Optical Problem; Optical Problem

  THIS FIBER URETERORENOSCOPE S/N:(B)(4) WAS DELIVERED TO THE CUSTOMER FOR A FEW MONTHS, THEN THE CUSTOMER USED IT WITHOUT ANY PROBLEMS UNTIL THE INCIDENT ON (B)(6) 2020. THE DOCTOR HAD COMPLETED THE FIRST PATIENT TREATMENT AND THEN STARTED THE SECOND TREATMENT OF ANOTHER PATIENT. HE COULD NOT COMPLETE THIS TREATMENT, BUT SUDDENLY THE DISPLAY IMAGE ON THE MONITOR WAS COMPLETELY BLURRED. A SECOND TIME WAS NECESSARY TO REMOVE THE STONE. THEY HAD A REGULAR APPOINTMENT FOR HEALTH CONTROL BETWEEN THE PATIENT AND THE HEALTH CARE INSTITUTION. THERE WAS NO DANGER TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10830284 ↗
• MalfunctionMay 1, 2018Material Integrity Problem; Optical Problem; No Display/Image; Material Integrity Problem; Optical Problem

  RICHARD WOLF MEDICAL INSTRUMENT CORPORATION WAS INFORMED BY FACILITY THAT DURING A PROCEDURE THE SCREEN GOES DARK. DEVICE COMPLAINT REPORT ANSWERS ARE PROVIDED BELOW: PRODUCT 7325.071 WILL BE RETURNED FOR INVESTIGATION. THE DEVICE WAS BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY OF ILLNESS TO THE PATIENT WHEN THE ISSUE OCCURRED. THE DELAY IN THE PROCEDURE PUT THE PATIENT AT RISK. A SIMILAR BACK-UP DEVICE WAS NOT AVAILABLE FOR USE. THE SCHEDULED PROCEDURE WAS COMPLETED. RWMIC PROVIDED COMPLAINT INFORMATION TO THE MANUFACTURER RW (B)(4) ON (B)(6) 2018. MANUFACTURER'S REPORT NUMBER IS INCLUDED IN THIS REPORT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7476544 ↗
• InjuryApr 27, 2017Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  FOLLOW UP #1. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) (CONTRACT MANUFACTURER) RECEIVED INVESTIGATION RESULTS FROM RICHARD WOLF (B)(4) (MANUFACTURER) ON 18SEP2017. THE FOLLOWING BOXES HAVE BEEN UPDATED/COMPLETED: DATE DESCRIPTION OF THIS REPORT, ALL MANUFACTURERS, DEVICE MANUFACTURER.

  Patient problems: Injury

  MAUDE report 6526186 ↗