BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID PNEUMATIC PROBE

    MDR report key: 16501422 · Received March 8, 2023

    Report

    Report Number
    3005099803-2023-01186
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 8, 2023
    Manufacturer
    ELECTRO MEDICAL SYSTEMS SA
    Product Code
    FFK
    PMA / PMN Number
    K012445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECTED DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF HOLES IN THE PACKAGES.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF LITHOCLAST RIGID PNEUMATIC PROBE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-01181 FOR THE FIRST LITHOCLAST RIGID PNEUMATIC PROBE, 3005099803-2023-01184 FOR THE SECOND LITHOCLAST RIGID PNEUMATIC PROBE AND 3005099803-2023-01186 FOR THE THIRD LITHOCLAST RIGID PNEUMATIC PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST RIGID PNEUMATIC PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THREE PNEUMATIC PROBES HAVE HOLES IN THEIR PACKAGES. A FOURTH LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777418 RIGID PNEUMATIC PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK ELECTRO MEDICAL SYSTEMS SA 840-733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown