BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERO-RENO FIBERSCOPE

    MDR report key: 24871746 · Received April 14, 2026

    Report

    Report Number
    9610595-2026-30350
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 14, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    PMA / PMN Number
    K181451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES IN RETROGRADE INTRARENAL SURGERY: A THREE YEAR RETROSPECTIVE STUDY". BACKGROUND: RETROGRADE INTRARENAL SURGERY (RIRS) HAS BECOME AN ESTABLISHED MINIMALLY INVASIVE TREATMENT FOR RENAL CALCULI. HOWEVER, STONE BURDEN, LOCATION, AND DENSITY MAY SIGNIFICANTLY INFLUENCE OUTCOMES. THIS STUDY EVALUATED THE EFFICACY, SAFETY, AND PREDICTORS OF STONE-FREE STATUS FOLLOWING RIRS IN A LARGE TERTIARY-CARE COHORT. METHOD(S): A RETROSPECTIVE ANALYSIS WAS PERFORMED ON 350 PATIENTS WHO UNDERWENT RIRS FOR RENAL CALCULI AT GAUHATI MEDICAL COLLEGE AND HOSPITAL BETWEEN 2022 AND 2025. DEMOGRAPHIC, RADIOLOGICAL, AND PERIOPERATIVE VARIABLES WERE ANALYZED. STONE SIZE, LOCATION, MULTIPLICITY, AND HOUNSFIELD UNIT (HU) DENSITY WERE ASSESSED AS PREDICTORS OF OUTCOME. STONE-FREE STATUS WAS DEFINED AS COMPLETE CLEARANCE OR RESIDUAL FRAGMENTS <3 MM ON FOLLOW-UP IMAGING. MULTIVARIATE LOGISTIC REGRESSION WAS USED TO IDENTIFY INDEPENDENT PREDICTORS OF STONE-FREE RATE (SFR) AND COMPLICATIONS. RESULT(S): THE MEAN PATIENT AGE WAS 49.8 +/- 15.2 YEARS, AND THE MEAN STONE SIZE WAS 14.2 +/- 6.3 MM. THE OVERALL SFR WAS 83.4%. SFR DECLINED SIGNIFICANTLY WITH INCREASING STONE SIZE: 95.5% FOR STONES <10 MM, 82.2% FOR 10-20 MM, AND 65.0% FOR >20 MM STONES (P < 0.001). LOWER-POLE STONES DEMONSTRATED INFERIOR CLEARANCE (71.7%) COMPARED WITH NON-LOWER POLE STONES (P=0.03). ON MULTIVARIATE ANALYSIS, STONE SIZE >20 MM (OR 0.34, P < 0.01), MULTIPLE STONES (OR 0.60, P=0.02), LOWER-POLE LOCATION (OR 0.59, P=0.03), AND HIGHER STONE DENSITY (OR 0.91 PER 100 HU INCREASE, P=0.004) INDEPENDENTLY PREDICTED LOWER STONE-FREE RATES. MEAN OPERATIVE TIME INCREASED WITH STONE SIZE (P < 0.001). PERIOPERATIVE COMPLICATIONS OCCURRED IN 12% OF PATIENTS, WITH MAJOR COMPLICATIONS IN LESS THAN 1%. CONCLUSION(S): RIRS IS A SAFE AND EFFECTIVE MODALITY FOR RENAL STONE MANAGEMENT, ACHIEVING HIGH STONE-FREE RATES WITH MINIMAL MORBIDITY. STONE SIZE, DENSITY, MULTIPLICITY, AND LOWER-POLE LOCATION ARE KEY DETERMINANTS OF SURGICAL SUCCESS AND SHOULD BE CONSIDERED DURING PREOPERATIVE PLANNING AND PATIENT COUNSELING. "" TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS TRANSIENT FEVER, MILD HEMATURIA, FLANK PAIN REQUIRING ORAL ANALGESICS 24 PATIENTS URINARY TRACT INFECTION REQUIRING ANTIBIOTICS, PROLONGED FEVER 14 PATIENTS ENDOSCOPIC INTERVENTION UNDER ANESTHESIA 1 PATIENT SEPSIS REQUIRING ICU CARE 1 PATIENT THERE WAS NO MALFUNCTION OF THE DEVICE WAS REPORTED IN THE LITERATURE CONTEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939184 URETERO-RENO FIBERSCOPE URETERO-RENO FIBERSCOPE FGB AIZU OLYMPUS CO., LTD. URF-P7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R 0.035-INCH TERUMO GLIDEWIRE| 9.5 FR URETERAL ACCESS SHEATH COOK FLEXOR| HOLMIUM: YAG LASER (QUANTA 100W, 200-M FIBER)