BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROPASS AS 10/12FR X 24 CM 5/BX

    MDR report key: 14166831 · Received April 21, 2022

    Report

    Report Number
    3003790304-2022-00055
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    December 17, 2021
    Report Date
    October 6, 2022
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    KNY
    UDI-DI
    00821925035317
    PMA / PMN Number
    K051593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE

    Description of Event or Problem · 0

    OLYMPUS REVIEWED A LITERATURE TITLED "PROGNOSTIC FACTORS FOR THE SAFETY AND EFFICACY OF RETROGRADE LASER LITHOTRIPSY: DATA FROM A CONTEMPORARY SERIES OF 155 CONSECUTIVE PATIENTS WITH SINGLE AND MULTIPLE LITHIASIS OF THE URINARY TRACT". THIS PROSPECTIVE STUDY WAS AIMED TO EVALUATE THE RESULTS AND COMPLICATIONS OF RETROGRADE ENDOSCOPIC LITHOTRIPSY FOR STONES LOCATED IN THE URINARY TRACT AND TO DETERMINE PROGNOSTIC FACTORS FOR TREATMENT OUTCOME. THE PROGNOSTIC FACTORS FOR THE STONE-FREE RATE (SFR) AFTER THE 1ST AND SUBSEQUENT SESSIONS AND OVERALL COMPLICATIONS WERE ASSESSED. PATIENTS WERE DIVIDED INTO SINGLE OR MULTIPLE LITHIASIS GROUPS (GROUPS A AND B RESPECTIVELY). A COMPARISON BETWEEN THESE TWO GROUPS WAS THEN CONDUCTED. OVERALL, 237 STONES WERE DETECTED IN 155 PATIENTS, REPRESENTING A MEAN BURDEN OF 1.53 STONES PER PATIENT. THE MEAN TOTAL STONE SIZE WAS 14.7 MM, THE INITIAL SFR WAS 80% AND THE FINAL SFR (AFTER A MEAN OF 1.23 SESSIONS PER PATIENT) WAS 94.2%. THE RATE OF COMPLICATIONS WAS 26.4%. MULTIVARIATE ANALYSIS REVEALED THAT PREOPERATIVE STENTING AND TOTAL STONE SIZE WERE INDEPENDENT PROGNOSTIC FACTORS OF INITIAL SFR, WHILE NO INDEPENDENT FACTORS WERE DETERMINED FOR FINAL SFR. AGE, TOTAL SIZE, AND STONES IN THE LOWER CALYX WERE INDEPENDENT FACTORS FOR COMPLICATIONS. IN GROUPS A AND B, 114 AND 41 CASES WITH SOLITARY AND MULTIPLE STONES WERE INCLUDED, RESPECTIVELY. EXCLUDING OPERATION TIME (P=0.002), NO SIGNIFICANT DIFFERENCES WERE RECORDED IN TERMS OF INITIAL (P=0.255) AND FINAL SFR (P=0.056), HOSPITAL STAY (P=0.308), THE MEAN NUMBER OF TREATMENTS (P=0.757), AND THE RATE OF COMPLICATIONS (P=0.218) BETWEEN THE TWO GROUPS. IN CONCLUSION, RETROGRADE ENDOSCOPIC MANAGEMENT OF MULTIPLE LITHIASIS HAS A FAVORABLE OUTCOME IRRESPECTIVE OF STONE LOCATION. OLDER PATIENTS WITH HIGHER BURDENS AND STONES IN THE LOWER CALYX SHOULD BE TREATED WITH CAUTION. THE AUTHORS USED THE FOLLOWING THREE OLYMPUS DEVICES: (B)(6): NT4W30115: LARGER STONE FRAGMENTS WERE REMOVED WITH EITHER A 1.8 OR A 3F NITINOL TIPLESS BASKET ((B)(4)). (B)(6): URF-P6,URETERO-RENO FIBERSCOPE: STONES PROXIMAL URETER AND ALL THE RENAL ONES WERE FRAGMENTIZED WITH A 4.9/7.95 F FLEXIBLE URETEROSCOPE (URFP6, OLYMPUS). (B)(6): 61024BX, UROPASS AS 10/12FR X 24 CM 5/BX: 10-12F ACCESS SHEATHS (UROPASS, GYRUS MEDICAL LTD.) WERE USED TO FACILITATE THE REINSERTION OF THE FLEXIBLE SCOPE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: URINARY TRACT SYMPTOMS (NUMBER OF EVENTS NOT REPORTED). FEVER ((NUMBER OF EVENTS NOT REPORTED). HEMATURIA (NUMBER OF EVENTS NOT REPORTED). UTI (NUMBER OF EVENTS NOT REPORTED). SEPSIS (11). URETERAL TRAUMA (NUMBER OF EVENTS NOT REPORTED). URETERAL STENOSIS (NUMBER OF EVENTS NOT REPORTED). ACUTE MYOCARDIAL INFARCTION(1). THIS REPORT IS 3 OF 3 FOR: (B)(6): 61024BX, UROPASS AS 10/12FR X 24 CM 5/BX: 10/12F ACCESS SHEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713659 UROPASS AS 10/12FR X 24 CM 5/BX SHEATH KNY GYRUS ACMI, INC 61024BX UNKNOWN(LITERATURE) 00821925035317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKNOWN LOT/SERIAL: NT4W30115, URF-P6