OES URETERO-RENO FIBERSCOPE OLYMPUS URF TYPE P5 (UDI 04953170286988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170286988), received between Jan 10, 2020 and Jun 8, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE OES URETERO-RENO FIBERSCOPE PRESENTED MULTIPLE BLACK DOTS ON THE IMAGE DUE TO MULTIPLE DENTS ON THE INSERTION TUBE OF THE SCOPE. ADDITIONALLY, THE RETROFLEX ANGULATION UP/DOWN MOVEMENTS WERE NOT GOOD, AND THERE WAS MILD LEAKAGE FROM THE CHANNEL. NO PATIENT HARM REPORTED. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THE BENDING TUBE REMAINED ANGLED DOWNWARDS AND STUCK BECAUSE THE WIRE WAS BROKEN. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE BENDING TUBE REMAINED ANGLED DOWNWARDS AND STUCK BECAUSE THE WIRE WAS BROKEN NOTED AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14637076 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED OF THE FOLLOWING LITERATURE ARTICLE: "COMPLICATIONS AFTER 4,500 FLEXIBLE URETEROSCOPY (ACADEMIC SINGLE CENTER EXPERIENCE)" BY BF GEAVLETE, R MULTESCU, C ENE, C BULAI, PA GEAVLETE. THE AIM OF THIS STUDY WAS TO EVALUATE THE INDICATIONS, LIMITS AND EFFICACY OF FLEXIBLE URETEROSCOPY ON A SIGNIFICANT NUMBER OF CASES AND ON A LONG FOLLOW-UP PERIOD. OVERALL COMPLICATIONS OCCURRED IN 18.9% OF THE PROCEDURES. DURING THE DIAGNOSTIC PROCEDURES INSPECTION OF THE ENTIRE UPPER URINARY TRACT WAS POSSIBLE IN 90% OF THE CASES (2,700 PATIENTS). STONE FREE RATE IN LITHIASIS CASES WAS 93.3% AFTER ONE PROCEDURE, 95.2% AFTER THE SECOND AND 97.3% AFTER THE THIRD ONE. THE STUDY CONCLUDED THAT RETROGRADE FLEXIBLE URETEROSCOPIC APPROACH WAS AN EFFICIENT DIAGNOSTIC AND TREATMENT METHOD FOR RENAL PATHOLOGY. ALSO THE COMPLICATION RATE IS RELATIVELY REDUCED, BUT A SERIOUS TRAINING IS INDICATED BEFORE USING THIS DEVICE. THE SURGEONS USED THE FOLLOWING OLYMPUS DEVICES IN THE PROCEDURES: OLYMPUS URF-P5, OLYMPUS URF-V, OLYMPUS URF-V23000. THE AUTHORS DID NO SPECIFY WHICH DEVICE WAS USED ON A SPECIFIC PATIENT WITH ADVERSE EVENTS. THEREFORE, THE ADVERSE EVENTS WILL BE REPORTED FOR EACH OLYMPUS DE

  Patient problems: Septic Shock; Unspecified Kidney or Urinary Problem

  MAUDE report 13472543 ↗
• MalfunctionDec 4, 2020Mechanical Jam; Mechanical Jam

  THE DEVICE WAS RETURNED TO THE OLYMPUS REPAIR CENTER BY THE CUSTOMER. DURING EVALUATION, THE REPAIR CENTER FOUND DETERIORATION OF THE ANGULATION MECHANISM DUE TO RUST. THERE WAS NO PATIENT INVOLVEMENT; THE REPORTABLE MALFUNCTION WAS FOUND DURING SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10943373 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS HOSPITALIZED FOR A PERIOD OF 4 DAYS AND THE SCOPE WAS ABLE TO BE REMOVED BY THE SURGEON WITHOUT SURGICAL INTERVENTION.

  Patient problems: No Information; Physical Entrapment

  MAUDE report 9578354 ↗
• InjuryJan 10, 2020Entrapment of Device; Device Dislodged or Dislocated

  ON DECEMBER 19, 2019, THE SERVICE CENTER RECEIVED MEDWATCH REPORT# 2019-1 THAT STATES, "PATIENT WAS UNDERGOING A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT URETEROSCOPY, LASER LITHOTRIPSY PROCEDURE. AS THE SURGEON PROCEEDED TO REMOVE THE URETERAL SCOPE FROM THE RIGHT URETER IT BECAME LODGED IN THE MID TO DISTAL URETER. THE SURGEON COULD NOT FREE THE SCOPE WITHOUT SIGNIFICANT TRACTION. DESPITE ATTEMPTS, THE SCOPE REMAINED IMPACTED WITHIN THE URETER. A 14 FRENCH FOLEY WAS REPLACED INTO THE BLADDER, AND URETERAL SCOPE WAS SECURED TO PATIENT'S RIGHT THIGH. THE PATIENT WAS THEN TRANSFERRED TO TERTIARY FACILITY FOR FURTHER EVALUATION AND MANAGEMENT." AS PART OF OUR INVESTIGATION, MULTIPLE FOLLOW-UPS WERE MADE TO THE USER FACILITY IN AN ATTEMPT TO GATHER ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTED SCOPE WAS NOT RETURNED TO THE SERVICE ENTER FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED A THIS TIME.

  Patient problems: Injury

  MAUDE report 9578241 ↗