OES URETERO-RENO FIBERSCOPE OLYMPUS URF TYPE P5 (UDI 04953170340307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170340307), received between Sep 20, 2018 and Nov 5, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, THAT THE SUBJECT DEVICE EXHIBITED PEELING OFF COATING OF THE INSERTION TUBE. THE ISSUE OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614721 ↗
• 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 20591654 ↗
• 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 20587584 ↗
• MalfunctionMar 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COATING OF THE URETERO-RENO FIBERSCOPE IMAGE GUIDE TUBE WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920618 ↗
• MalfunctionAug 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES URETERO-RENO FIBERSCOPE WAS LEAKING AT THE DISTAL END. THE ISSUE WAS FOUND DURING CLEANING, DISINFECTING AND SANITIZING. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THE CONNECTING TUBE HAD PEELING (4MM OR MORE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17456002 ↗
• MalfunctionJun 1, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A THIRD PARTY DISTRIBUTOR REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER, THAT THE INSERTION TUBE WAS DAMAGED ON A FIBERSCOPE "URF-P5", SET E. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND UPON ESTIMATION, THERE WERE METAL WIRES PROTRUDING FROM THE INSERTION TUBE. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038889 ↗
• MalfunctionMay 19, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE COVER ON THE FIBERSCOPE "URF-P5", SET E WAS PEELED OFF. NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION IT WAS FOUND THAT THE INSERTION TUBE COATING WAS PEELING OFF. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION THAT WAS NOTED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14443374 ↗
• MalfunctionApr 4, 2022Peeled/Delaminated; Peeled/Delaminated

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, DURING PREPARATION FOR USE FOR A THERAPEUTIC INTERNAL LITHOTRIPSY, THE INSERTION PART ON THE OES URETERO-RENO FIBERSCOPE WAS LEAKING. THE PROCEDURE WAS NOT DELAYED MORE THAN FIFTEEN (15) MINUTES. THE PATIENT WAS NOT UNDER ANESTHESIA. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THE EVIS EXERA III VIDEO SYSTEM CENTER. NO PATIENT HARM REPORTED. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THE COATING ON THE INSERTION TUBE WAS PEELING OFF. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE COATING ON THE INSERTION TUBE WAS PEELING OFF NOTED AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13993815 ↗
• MalfunctionFeb 23, 2022Peeled/Delaminated; Peeled/Delaminated

  CUSTOMER SENT REPAIR REQUEST FOR DEVICE LG (LIGHT GUIDE) SUSPICION OF BREAKAGE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. DEVICE EVALUATION FOUND COATING PEELING AT THE INSERTION PART (MAJOR AXIS 4MM OR MORE ). THIS REPORT IS BEING SUBMITTED FOR COATING PEELING AT THE INSERTION PART OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589062 ↗
• MalfunctionJan 11, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY REPORTED THAT THE FLEXIBLE SCOPE SHEATH IS TORN AND WAS PEELING AT THE TIP. THE CUSTOMER MENTIONED THAT THE DEVICE WAS HIT BY A LASER FIBER. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO AN UNKNOWN DIAGNOSTIC PROCEDURE. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, INSERTION TUBE PEELING WAS NOTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13220445 ↗
• MalfunctionDec 8, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF MORE THAN 4MM DURING THE INCOMING INSPECTION FOR THE REPAIR OF THE SUBJECT DEVICE AT OLYMPUS (B)(4). THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960511 ↗
• MalfunctionOct 18, 2021Defective Component; Defective Component

  A USER FACILITY REPORTED TO OLYMPUS THAT THE OES URETERO-RENO FIBERSCOPE HAS A BROKEN FIBER. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, ANGLE CORD DAMAGE WAS NOTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647652 ↗
• InjurySep 20, 2018Difficult to Advance; Difficult to Advance

  ONE OF 2. OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC URETEROSCOPY, THE SURGEON WAS HAVING TROUBLE ACCESSING THE LEFT DISTAL URETER USING THE URF-P5 DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SEPARATE LONG RIGID URETEROSCOPE WAS SUBSTITUTED. WHILE USING THE REPLACEMENT URETEROSCOPE, THE SURGEON NOTICED THAT THE URETER HAD DETACHED FROM THE KIDNEY. AFTERWARDS THE PATIENT WAS INFORMED THAT A SEPARATE LAPAROSCOPIC INTERVENTION IS INDICATED TO REPAIR THE AVULSED URETER.

  Patient problems: Injury

  MAUDE report 7896397 ↗