URETERO-RENO VIDEOSCOPE OLYMPUS URF TYPE V (UDI 04953170340321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 04953170340321), received between May 30, 2019 and Nov 19, 2024 — classified as 13 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (23 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE URETERO-REINDEER VIDEOSCOPE¿ A-RUBBER (BENDING SECTION COVER) HAS TRUNCATION (PEELING). THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723333 ↗
• MalfunctionNov 14, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE URETERO-RENO VIDEOSCOPE HAD THE COATING PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684146 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED LITERATURE TITLED "A NEWLY DEVELOPED HEMATURIA GRADING SYSTEM MAY PREDICT THE STATUS OF STONE-FREE AND ACUTE PYELONEPHRITIS OF MINIMALLY INVASIVE RENAL STONE SURGERY". THE AIM OF THIS STUDY WAS TO EVALUATE THE LEVEL OF HEMATURIA AND THE PRESENCE OF CLOTS DURING RETROGRADE INTRARENAL SURGERY (RIRS) AND MINIATURIZED PERCUTANEOUS NEPHROLITHOTOMY (MPCNL) TO PREDICT SURGICAL OUTCOMES. THE DATA OF PATIENTS WHO UNDERWENT RIRS AND MPCNL WERE ANALYZED SEPARATELY. A HEMATURIA GRADING (HG) SYSTEM WAS CLASSIFIED INTO FIVE GRADES BASED ON THE PRESENCE OF BLOOD CLOTS AND ANY VISIBLE STONES ACCORDING TO THE IRRIGATION SETTINGS. INTER-OBSERVER RELIABILITY OF THE GRADING SYSTEM WAS ASSESSED USING INTRA-CLASS CORRELATION AND SPEARMAN¿S RHO. THE HG SYSTEM SHOWED HIGH AGREEMENT AMONG EXAMINERS, WITH HIGH INTRA-CLASS RELIABILITY AND A STRONG CORRELATION BETWEEN RIRS AND MPCNL GROUPS. THE STONE DENSITY OF THE HOUNS-FIELD UNIT WAS THE MOST IMPORTANT FACTOR IN DETERMINING THE HEMATURIA ACROSS THE DEVELOPMENT AND VALIDATION GROUPS OF RIRS AND MPCNL PATIENTS. MULTIVARIATE LOGISTIC REGRESSION ANALYSIS SHOWED THAT THE HG SYSTEM WAS A SIGNIFICANT PREDICTOR FOR REMNANT STONES IN THE PCNL GROUP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20587610 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE URETERO-RENO VIDEOSCOPE IMAGE GUIDE (IG) HOSE RESIN PART FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528453 ↗
• MalfunctionOct 23, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519428 ↗
• MalfunctionOct 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE HAD DEFORMATION OF ANGLE SHAFT AND THE BENDING SECTION CANNOT BE CONTROLLED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507514 ↗
• MalfunctionOct 17, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED A BROKEN, PROTRUDED, AND LEAKING BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473176 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED THE RESIN PART OF THE IMAGE GUIDE SNAKE PIPE HAD FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434110 ↗
• MalfunctionOct 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RENO VIDEOSCOPE EXHIBITED FORCEPS WERE STUCK IN THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388560 ↗
• InjurySep 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A TRANSURETHRAL URETEROSCOPY FOR THE REMOVAL OF LEFT URETERAL STENT, (HOLMIUM LASER LITHOTRIPSY FOR LEFT KIDNEY STONES UNDER URETEROSCOPY, AND PLACEMENT OF THE LEFT URETERAL STENT TUBE) PROCEDURE, THE UTERORENOVIDEOSCOPE CONTROL KNOB WAS FOUND TO BE MALFUNCTIONING. IT WAS NOT POSSIBLE TO CONTROL THE DIRECTION OF THE KNOB AND SURGERY COULD NOT BE CONTINUED. AS SUCH ANOTHER SET OF URETEROSCOPE WAS CONNECTED AND SURGERY WAS CONTINUED AND COMPLETED. THE PROCEDURE WAS DELAYED BY 2-3 HOURS. THE PATIENT'S VITAL SIGNS WERE CLOSELY MONITORED DURING THE PROCESS. THE PATIENT WAS NOT AFFECTED OR HARMED AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330562 ↗
• MalfunctionAug 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20051096 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE URETERO-RENO VIDEOSCOPE EXHIBITED THE RESIN PART OF THE IMAGE GUIDE HOSE HAS FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036223 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED OF PLASTIC PART FELL OFF INSERTION PART. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032919 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED A DETACHMENT OF THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795233 ↗
• MalfunctionJul 11, 2024Degraded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEOSCOPE EXHIBITED CORROSION ON THE ANGLE MECHANISM, BENDING SECTION COULD NOT BE CONTROLLED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721268 ↗
• MalfunctionJul 3, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE VIDEOSCOPE EXHIBITED INSERTION TUBE METAL WIRE WAS PROTRUDED AT BENDING SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670865 ↗
• MalfunctionJul 2, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659248 ↗
• MalfunctionJun 4, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETHRO-RENO VIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE CHANNEL TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462444 ↗
• MalfunctionMay 22, 2024Component Missing; Component Missing

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED A PART OF THE CONNECTING TUBE FALLING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371616 ↗
• MalfunctionApr 16, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE URETERO-RENO VIDEOSCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS) OF AEROMONAS HYDROPHILA. 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 19115092 ↗
• MalfunctionApr 12, 2024Scratched Material; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED THE FORCEPS CHANNEL PORT WAS SHAVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097741 ↗
• MalfunctionMar 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO VIDEOSCOPE EXHIBITED A HOLE IN THE DISTAL SHEATH ALONG WITH A DEFORMED BENDING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921178 ↗
• MalfunctionFeb 9, 2024Separation Failure; Separation Failure

  THE MALFUNCTION OCCURRED DURING A FLEXIBLE URETERORENOSCOPY, DIAGNOSTIC/THERAPEUTIC PROCEDURE. ANOTHER DEVICE WAS USED TO FINISH. THERE WAS ONLY A FEW MINUTES DELAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678389 ↗
• MalfunctionJan 12, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A FOREIGN OBJECT PRESENT NEAR THE EXIT OF THE FORCEPS TIP OF THE VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503333 ↗
• MalfunctionJan 10, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS, THE URETERO-RENO VIDEOSCOPE HAD AN AIR LEAK. THE ISSUE WAS FOUND DURING AN UNKNOWN EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FORCEPS STOPPER IS LOOSE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489781 ↗