BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 493723 · Received October 23, 2003

    Report

    Report Number
    MW1029983
    Event Type
    Other
    Date Received
    October 23, 2003
    Date of Event
    September 17, 2003
    Report Date
    October 23, 2003
    Manufacturer
    KARL STORZ CO.
    Product Code
    GEN
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT, UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE WITH PELVIC LYMPH NODE DISSECTION IN 2003. A SMOOTH GRASPER WAS USED DURING THE PROCEDURE AND THE JAW BROKE OFF. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND THE BROKEN PIECE WAS RETRIEVED. THE PT HAS RECOVERED FROM THE OPEN SURGERY WITH NO ADVERSE IMPACT. THE HOSPITAL DID NOT SAVE THE SUBJECT FORCEPS AND THE RETRIEVED BROKEN PIECE, NOR DID THEY HAVE ANY RECORDS OF THE PRODUCT NUMBER OF THE SUBJECT FORCEPS. THEY THINK IT WAS A KARL STORZ FORCEPS. COMPANY COULD NOT IDENTIFY WHAT THE "SMOOTH" FORCEPS COULD BE, NOR ARE COMPANY CERTAIN THAT IT WAS A KARL STORZ PRODUCT. THEREFORE, COMPANY WILL NOT FILE A MEDWATCH REPORT OR TAKE ANY CORRECTIVE ACTIONS AT THIS TIME.

    Description of Event or Problem · 1

    DURING PROCEDURE, JAW OF SMOOTH GRASPER BROKE OFF INSIDE PT AND COULD NOT BE FOUND LAPAROSCOPICALLY. PT HAD TO BE OPENED AND PIECE RETRIEVED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/23/04: MFR CONTACTED THE INITIAL REPORTER AND LEARNED THAT, THE PT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE WITH PELVIC LYMPH NODE DISSECTION. A SMOOTH GRAPSER WAS USED DURING THE PROCEDURE AND THE JAW BROKE OFF. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND THE BROKEN PIECE WAS RETRIEVED. THE PT WAS RECOVERED FROM THE OPEN SURGERY WITH NO ADVERSE IMPACT. THE HOSPITAL DID NOT SAVE THE SUBJECT FORCEPS AND THE RETRIEVED BROKEN PIECE, NOR DID THEY HAVE ANY RECORDS OF THE PRODUCT NUMBER OF THE SUBJECT FORCEPS. THEY THINK IT WAS A KARL STORZ FORCEPS. IT WAS THROUGH FDA'S REPORT THAT MFR FIRST LEARNED ABOUT THIS INCIDNET. MFR COULD NOT IDENTIFY WHAT THE "SMOOTH" FORCEPS COULD BE, NOR IS MFR CERTAIN THAT IT WAS A KARL STORZ PRODUCT. THEREFORE, MFR WILL NOT FILE A MEDWATCH REPORT OR TAKE ANY CORRECTIVE ACTIONS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SMOOTH GRASPER GEN KARL STORZ CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other