BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROHYDRAULMIC LITHOTRIPSY PROBE

    MDR report key: 39046 · Received September 19, 1996

    Report

    Report Number
    1418479-1996-00009
    Event Type
    Injury
    Date Received
    September 19, 1996
    Date of Event
    August 20, 1996
    Report Date
    August 22, 1996
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FFK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE METAL TIP OF AN ELECTROHYDRAULIC LITHOTRIPSY PROBE CAME OFF IN A PT'S URETER AS THE PHYSICIAN WAS ATTEMPTING TO BREAK A URETER STONE. THE METAL PART WAS NOT RETRIEVABLE. A SECOND SURGICAL PROCEDURE WAS DONE TO REMOVE THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROHYDRAULMIC LITHOTRIPSY PROBE * FFK RICHARD WOLF MEDICAL INSTRUMENTS CORP. 2280.435 102951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention
    2
    3