BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMS SWISS LITHOCLAST LITHOTRIPTER

    MDR report key: 21194243 · Received January 20, 2025

    Report

    Report Number
    2124215-2024-83924
    Event Type
    Injury
    Date Received
    January 20, 2025
    Date of Event
    December 1, 2010
    Report Date
    January 20, 2025
    Manufacturer
    ELECTRO MEDICAL SYSTEMS SA
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FROM DECEMBER 2010 TO AUGUST 2013. BLOCK D4: THE SUSPECTED DEVICE UPN AND LOT NUMBER COULD NOT BE PROVIDED. THE EXACT DEVICE EXPIRATION DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT EXPIRED. BLOCK G2: LITERATURE SOURCE SHUZO HAMAMOTO, MD, PHD, TAKAHIRO YASUI, MD, PHD, ATSUSHI OKADA, MD, PHD, SATOSHI KOIWA, MD, KAZUMI TAGUCHI, MD, YASUNORI ITOH, MD, PHD, NORIYASU KAWAI, MD, PHD, YOSHIHIRO HASHIMOTO, MD, PHD, KEIICHI TOZAWA, MD, PHD, AND KENJIRO KOHRI, MD, PHD (2015). EFFICACY OF ENDOSCOPIC COMBINED INTRARENAL SURGERY IN THE PRONE SPLIT-LEG POSITION FOR STAGHORN CALCULI. JOURNAL OF ENDOUROLOGY, 19-24. HTTPS://DOI.ORG/ 10.1089/END.2014.0372.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN JOURNAL OF ENDOUROLOGY THAT A STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY OF ENDOSCOPIC COMBINED INTRARENAL SURGERY IN THE PRONE SPLIT-LEG POSITION FOR STAGHORN CALCULI. THIS RETROSPECTIVE STUDY ANALYZED THE RECORDS OF 42 PATIENTS WITH STAGHORN CALCULI TREATED WITH ENDOSCOPIC COMBINED INTRARENAL SURGERY (ECIRS) AT A SINGLE CENTER BETWEEN DECEMBER 2010 AND AUGUST 2013. ENDOSCOPIC COMBINED INTRARENAL SURGERY (ECIRS) INVOLVED SIMULTANEOUS PROCEDURES BY TWO UROLOGISTS, FLEXIBLE URETEROSCOPY WITH A LASER FIBER VIA A URETERAL ACCESS SHEATH AND LITHOCLAST LITHOTRIPSY THROUGH A MINI-PERCUTANEOUS TRACT, PERFORMED IN THE PRONE SPLIT-LEG POSITION. THESE PROCEDURES INVOLVED A LITHOCLAST DISPOSABLE. WITHIN THE REPORTED COMPLICATIONS, ONE PATIENT EXPERIENCED UREHTERAL INJURY, THREE EXPERIENCED URINARY TRACT PERFORATION AND FOUR HAD FEVER. ADDITIONALLY, ONE PATIENT REQUIRED BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556551 EMS SWISS LITHOCLAST LITHOTRIPTER LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK ELECTRO MEDICAL SYSTEMS SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R