BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEMI- RIGID GRASPING FORCEPS

    MDR report key: 6989191 · Received October 30, 2017

    Report

    Report Number
    9610617-2017-00091
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    September 13, 2017
    Report Date
    October 2, 2017
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FGC
    UDI-DI
    04048551073681
    PMA / PMN Number
    K945907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRASPING FORCEPS WERE NOT RETURNED TO KARL STORZ FOR EVALUATION. THE HOSPITAL SENT THE FORCEPS TO IMS A THIRD PARTY REPAIR FACILITY. ALTHOUGH THE PRODUCT STILL CARRIES KARL STORZ BRAND NAME, WE CANNOT BE CERTAIN WHETHER THAT WAS STILL THE ORIGINAL KS PRODUCT.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A ESWL UERETERAL STONE AND CYSTOSCOPY WITH STENT REMOVAL PROCEDURE, DOCTOR NOTED THAT ONE OF THE JAWS ON GRASPING FORCEPS BROKE OFF INTO PATIENT'S BLADDER. DOCTOR LOCATED BROKEN PIECE AND ATTEMPTED TO RETRIEVE IT, BUT HE WAS UNABLE TO DO SO. HE BELIEVES THAT PATIENT SHOULD PASS IT ON HIS OWN, SINCE IT WAS SMALLER THAN THE STONES THAT THEY WERE REMOVING. PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768860 SEMI- RIGID GRASPING FORCEPS GRASPING FORCEPS FGC KARL STORZ GMBH & CO. KG 27023FM PT02 04048551073681

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR