URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3 (REF N5782022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170435119), received between May 2, 2023 and Mar 21, 2025 — classified as 1 injury, 76 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K181451); they may or may not involve this specific model.

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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE VIDEOSCOPE HAD FOREIGN MATERIAL FALLING OFF FROM THE CHANNEL DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21663340 ↗
• MalfunctionJan 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED NOTCHED DISTAL HEAD WORKING CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178081 ↗
• MalfunctionDec 12, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN IMAGE PROBLEM. THE ISSUE OCCURRED DURING A DIAGNOSTIC URETEROSCOPY PROCEDURE THAT WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913811 ↗
• MalfunctionNov 27, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791653 ↗
• MalfunctionNov 18, 2024Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709520 ↗
• MalfunctionNov 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE URETERO-RENO VIDEOSCOPE HAD A LEAK AT THE DISTAL END. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659459 ↗
• MalfunctionNov 8, 2024Break; No Display/Image; Break; No Display/Image

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE FLEX VIDEOSCOPE BENDING TUBE IS BROKEN AND THE METAL IS STICKING OUT ALONG WITH LOSS OF IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638811 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED THAT THE BENDING SECTION AND BENDING SECTION COVER ARE BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625123 ↗
• MalfunctionNov 4, 2024Material Deformation; Material Deformation

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO RENO VIDEOSCOPE EXHIBITED DEFORMATION INSIDE THE INSTRUMENT CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604476 ↗
• MalfunctionOct 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO RENO VIDEOSCOPE EXHIBITED A BROKEN BENDING TUBE AND THE METAL BRAIDS WERE STICKING OUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560108 ↗
• MalfunctionOct 25, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED PEELING OF THE COATING ON THE INSERTION SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531851 ↗
• MalfunctionOct 24, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING INSPECTION AND TESTING OF THE VIDEOSCOPE, THE BENDING TUBE SKELETON WAS FOUND PROTRUDING THROUGH THE DISTAL SHEATH. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526514 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THERE WAS A GAP ON THE URETERO-RENO VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519383 ↗
• MalfunctionOct 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THE RENO VIDEOSCOPE EXHIBITED FOREIGN OBJECT NEAR THE FORCEPS OUTLET. THE ISSUE IS UNKNOWN AS TO WHEN IT OCCURRED. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476620 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THERE WAS FOREIGN MATERIAL IN THE BIOPSY CHANNEL OF THE VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450737 ↗
• MalfunctionOct 11, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE URETERO-RENO VIDEOSCOPE TESTED POSITIVE FOR 312 COLONY FORMING UNITS (CFUS) OF MICROCOCCUS LUTEOUS. ALL CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428388 ↗
• MalfunctionOct 9, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE URETERO-REINDEER VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407297 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT THE URETERO-RENO VIDEOSCOPE HAD PLIERS MOUTH BROKEN (DAMAGED THE INSTRUMENT CHANNEL PORT). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385833 ↗
• MalfunctionOct 1, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO VIDEOSCOPE EXHIBITED A FOREIGN OBJECT IN THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349043 ↗
• MalfunctionSep 20, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE URETERO-RENO VIDEOSCOPE HAD GAUGES AND TEARS WITH A HOLE IN THE INSTRUMENT CHANNEL PORT. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267569 ↗
• MalfunctionSep 11, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED LOCKED ANGULATION DUE TO WEAR OF THE ANGLE WIRE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190521 ↗
• InjurySep 9, 2024Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ELECTIVE KIDNEY STONE SURGERY, A RIGID CYSTOSCOPE WAS USED TO LOOK INTO THE BLADDER, FOLLOWED BY A SHORT RIGID URETERSCOPE. THE URETEROSCOPE WAS REMOVED AND AN ACCESS SHEATH WAS INSERTED FOLLOWED BY THE SUBJECT DEVICE. THE KIDNEY STONE WAS FOUND AND LASERED FOR APPROXIMATELY 2 MINUTES USING A LASER FIBRE. FOLLOWING THIS, A RETRIEVAL BASKET WAS INSERTED TO REMOVE THE STONE FROM THE URETER. UPON TRYING TO REMOVE THE SUBJECT DEVICE IT WAS NOTED THAT THERE WAS A LOT RESISTANCE AND THE SUBJECT DEVICE WAS NOT COMING OUT OF THE URETER. THE RETRIEVAL BASKET WAS REMOVED FROM THE PATIENT. THE ACCESS WAS BOTH REMOVED FROM THE URETER/URETHRA. X-RAY WAS USED TO SEE IF THERE WAS ANYTHING OBVIOUS BLOCKING THE SUBJECT DEVICE FROM COMING OUT OF THE URETER. THE SURGEON RE-ENTERED THE BLADDER USING A CYSTOSCOPE IN ORDER TO SEE FROM THE INSIDE WHAT WAS HAPPENING. WHEN IN THE BLADDER LOOKING AT THE SUBJECT DEVICE IN THE URETER IT WAS NOTED SILVER (METAL) COULD BE SEEN NEAR THE FLEXIBLE BENDING SECTION OF THE TIP WHERE THE BLACK RUBBER BENDING SECTION WOULD USUALLY BE. THE SURGEON WAS UNABLE TO REMOVE THE SUBJECT DEVICE WITHOUT TEARING AND TAKING PART OF THE URETER WITH TH

  Patient problems: Hematuria; Laceration(s); Unspecified Kidney or Urinary Problem

  MAUDE report 20174539 ↗
• MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO VIDEOSCOPE EXHIBITED CONNECTING TUBE COATING PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156917 ↗
• MalfunctionSep 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS OBSERVED, DURING THE DEVICE. THAT THE RENO VIDEOSCOPE, EXHIBITED A DEFECTIVE BENDING SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153878 ↗
• MalfunctionSep 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED THAT THE OPERATION SECTION ANGLE WAS NOT WORKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147360 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181451. One submission often covers many models, so check the product and lot details in each record.

• Z-0348-2024 · Sep 25, 2023 · Open, Classified
  Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.