BOA VISION 7355071Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04055207054840), received between Jul 15, 2020 and Jul 6, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Leak/Splash; No Pressure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUSTOMER COMPLAINED THAT THE INSTRUMENT DOES NOT HOLD ANY PRESSURE AND NOTICED LEAKING BLACK FLUID. THEY CLAIMED THAT THE DEVICE MAY HAVE POSSIBLY BEEN DAMAGED DURING THE PROCEDURE. THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. THE SCHEDULED PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25720558 ↗
• MalfunctionMay 6, 2026Difficult to Insert

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096721 ↗
• InjuryJan 21, 2026Difficult to Insert

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135028 ↗
• InjuryJan 21, 2026Difficult to Insert

  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 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134993 ↗
• MalfunctionFeb 16, 2023Loss of or Failure to Bond; Difficult to Remove; Deformation Due to Compressive Stress; Loss of or Failure to Bond; Difficult to Remove; Deformation Due to Compressive Stress

  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.

  Patient problems: Insufficient Information

  MAUDE report 16385091 ↗
• MalfunctionFeb 16, 2023Loss of or Failure to Bond; Difficult to Remove; Deformation Due to Compressive Stress; Loss of or Failure to Bond; Difficult to Remove; Deformation Due to Compressive Stress

  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.

  Patient problems: Insufficient Information

  MAUDE report 16385090 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Mechanical Problem

  ON DECEMBER 26TH 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE SCOPE WAS JUST TRANSFERRED INTO THE FACILITY. IT WAS PROCESSED BY THE CENTRAL PROCESSING DEPARTAMENT. IT WAS OPENED UP FOR THE FIRST CASE AND WE WERE UNABLE TO GET A 200 LASER FIBER THROUGH THE TIP OF THE SCOPE. THE LASER FIBER WAS REMOVED AND A GUIDE WIRE WAS THEN PLACED THROUGH THE SCOPE AGAIN TO SEE IF THERE WAS AN ISSUE WITH THE SCOPE. THE GUIDE WIRE WENT THROUGH FINE. THE GUIDE WIRE WAS THEN REMOVED, AND THE 200 LASER FIBER WAS TRIED ONE MORE TIME. IT STILL WOULDN'T GO THROUGH THE DISTAL TIP OF THE SCOPE. IT WAS REMOVED FROM THE FIELD AND THEN PRESSURE TESTED BY MYSELF (B)(6) WHERE IT PASSED THE TEST. I TOOK THE SCOPE TO DECONTAM TO SEE IF I COULD GET A CLEANING BRUSH THROUGH, TO WHERE I FOUND IT WAS DIFFICULT TO GET IT TO PASS THROUGH THE DISTAL TIP. (B)(6) THEN CHECKED THE SCOPE OUT FOR HIM SELF AND HE SAID IT SEEMS FINE. TRIED TO USE THE SCOPE AGAIN AND IT STILL WAS UNABLE TO PASS A 200 LASER FIBER THROUGH. WILL THE DEVICE BE RETURNED? YES . WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10279685 ↗