URETERO-RENO FIBERSCOPE OLYMPUS URF-P7 (REF N5781844)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04953170435096), received between Jun 2, 2023 and Feb 26, 2025 — classified as 3 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (19 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. 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Material Discolored; Material Discolored

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT FLEXIBLE SCOPE EXHIBITED THE FORCEPS STOPPER MOUTHPIECE WAS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469662 ↗
• MalfunctionFeb 18, 2025Material Perforation; Material Perforation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE EXHIBITED A PERFORATION OF THE BIOPSY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404819 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "UNDERSTANDING THE ROLE OF URETERAL ACCESS SHEATH IN PREVENTING POST-OPERATIVE INFECTIOUS COMPLICATIONS IN STONE PATIENTS TREATED WITH URETEROSCOPY AND HO:YAG LASER LITHOTRIPSY: RESULTS FROM A TERTIARY CARE REFERRAL CENTER". THE USE OF URETERAL ACCESS SHEATHS (UAS) LIMITS THE IRRIGATION-INDUCED INCREASE IN INTRARENAL PRESSURE DURING URETEROSCOPY (URS). WE INVESTIGATED THE RELATIONSHIP BETWEEN UAS AND RATES OF POSTOPERATIVE INFECTIOUS COMPLICATIONS IN STONE PATIENTS TREATED WITH URS. DATA FROM 369 STONE PATIENTS TREATED WITH URS FROM SEPTEMBER 2016 TO DECEMBER 2021 AT A SINGLE INSTITUTION WERE ANALYZED. UAS (10/12 FR) PLACEMENT WAS ATTEMPTED IN CASE OF INTRARENAL SURGERY. THE CHI-SQUARE TEST WAS USED TO ASSESS THE RELATIONSHIP BETWEEN THE USE OF UAS AND FEVER, SEPSIS, AND SEPTIC SHOCK. UNIVARIABLE AND MULTIVARIABLE LOGISTIC REGRESSION ANALYSES TESTED THE ASSOCIATION OF PATIENTS¿ CHARACTERISTICS AND OPERATIVE DATA AND THE RATE OF POSTOPERATIVE INFECTIOUS COMPLICATIONS. FULL DATA COLLECTION OF 451 URS PROCEDURES WAS AVAILABLE. OVERALL, UAS WAS USED IN 220 (48.8%) PROCEDURES. AS FOR POSTOPERATIVE INFECTIOUS SEQUALAE, WE RECORDED FEVER (N = 52; 11.5%

  Patient problems: Sepsis; Septic Shock

  MAUDE report 20591641 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "PREDICTIVE FACTORS FOR PROLONGED OPERATIVE TIME IN URETEROSCOPIC LITHOTRIPSY FOR URETERAL STONES". LITERATURE SUMMARY INTRODUCTION: A PROLONGED OPERATIVE TIME OF LITHOTRIPSY WITH URETEROSCOPY FOR UROLITHIASIS INCREASES THE RISK OF INFECTIOUS COMPLICATIONS; HOWEVER, FEW REPORTS HAVE INVESTIGATED THE FACTORS PROLONGING THE OPERATIVE TIME FOR URETERAL STONES. WE INVESTIGATED THE FACTORS ASSOCIATED WITH LONGER OPERATIVE TIME IN URETEROSCOPY FOR URETERAL STONES. METHODS: THIS RETROSPECTIVE COHORT STUDY ANALYZED PATIENTS WHO UNDERWENT RETROGRADE URETEROSCOPIC LITHOTRIPSY FOR URETERAL STONES AND ACHIEVED AN ENDOSCOPIC STONE-FREE STATUS BETWEEN APRIL 2019 AND JULY 2022. PATIENTS WERE CLASSIFIED INTO TWO GROUPS BASED ON AN OPERATIVE TIME OF =90 MINUTES OR <90 MINUTES. WE COMPARED THE PATIENT AND STONE CHARACTERISTICS AND SURGICAL OUTCOMES, AND INVESTIGATED THE FACTORS ASSOCIATED WITH A PROLONGED OPERATIVE TIME. RESULTS: THE COHORT COMPRISED 519 PATIENTS, WITH 58 PATIENTS IN THE GROUP WITH AN OPERATIVE TIME OF =90 MINUTES. COMPARED TO THE SHORTER OPERATIVE TIME GROUP, THE LONGER OPERATIVE TIME GROUP HAD A SIGNIFICANTLY GREATE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 20588031 ↗
• MalfunctionOct 31, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT FOREIGN MATERIAL CAME OUT OF THE TIP OF THE URETERO-RENO FIBERSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576783 ↗
• MalfunctionOct 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO FIBERSCOPE EXHIBITED FOREIGN MATERIAL ON BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511508 ↗
• MalfunctionOct 22, 2024Component Missing; Component Missing

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO FIBERSCOPE EXHIBITED BENDING SECTION COVER WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504206 ↗
• MalfunctionOct 11, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THE FIBERSCOPE HAD FOREIGN OBJECT FALL FROM THE CHANNEL. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427408 ↗
• MalfunctionOct 7, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO RENO FIBERSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389821 ↗
• MalfunctionOct 2, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FIBERSCOPE EXHIBITED THE INSERTION SECTION FLEXIBLE TUBE COATING PEELED OFF AT A MAXIMUM WIDTH OF 4MMOR MORE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354246 ↗
• MalfunctionSep 14, 2024Failure to Clean Adequately; Failure to Clean Adequately

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218664 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A BROKEN BENDING SECTION COVER, METAL JOINTS WERE LIFTING IN BENDING SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206306 ↗
• MalfunctionSep 7, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FIBERSCOPE EXHIBITED FORCEPS CHANNEL PORT IS SHAVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164674 ↗
• MalfunctionSep 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE EXHIBITED A FOREIGN OBJECT IN FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152873 ↗
• MalfunctionSep 5, 2024Crack; Crack

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE FORCEPS PLUG NOZZLE WAS FOUND CHIPPED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147897 ↗
• MalfunctionAug 23, 2024Mechanical Problem; Stretched; Mechanical Problem; Stretched

  IT WAS REPORTED THE FIBERSCOPE HAD A TIP ANGLE LOCK. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056369 ↗
• MalfunctionAug 22, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE EXHIBITED FOREIGN MATERIALS THAT ARE COMING OUT OF THE TIP DUE TO CLOGGING OF THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038237 ↗
• MalfunctionAug 15, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE URETERO-RENO FIBERSCOPE TESTED POSITIVE FOR <1 COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS WARNERI, 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 19994454 ↗
• MalfunctionAug 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETO-RENO FIBERSCOPE EXHIBITED FOREIGN MATERIAL ON THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938141 ↗
• MalfunctionAug 6, 2024Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately

  IT WAS REPORTED THE URETERO-RENO FIBERSCOPE HAD AN IMAGE PROBLEM, AND A PIECE FLUSHED OUT OF THE CHANNEL. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917410 ↗
• MalfunctionJun 18, 2024Degraded; Degraded

  IT WAS REPORTED, THE FIBERSCOPE HAD AN EXPOSED TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559913 ↗
• MalfunctionJun 13, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FIBERSCOPE EXHIBITED FOREIGN MATERIAL IN THE EYEPIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531271 ↗
• MalfunctionJun 10, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE URETERO-RENO FIBERSCOPE INSERTION SECTION FLEXIBLE TUBE COATING WAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19501950 ↗
• MalfunctionJun 7, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FIBERSCOPE EXHIBITED FOREIGN OBJECTS IN THE CHANNEL TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491035 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO FIBERSCOPE FORCEPS SUCTION CONNECTER IS SHAVED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445841 ↗

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.