BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STARZ ENDOSCOPY - AMERCUE INC

    MDR report key: 511838 · Received February 12, 2004

    Report

    Report Number
    511838
    Event Type
    Injury
    Date Received
    February 12, 2004
    Date of Event
    October 17, 2003
    Report Date
    February 6, 2004
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HCZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL ELECTROCAUTERY FULGURATION OF BOTH TUBES (LAPARO-SCOPIC TUBAL LIGATION). THE NEXT DAY EXPERIENCING ABDOMINAL PAIN, REQUIRED ADDITIONAL SURGERY EXPLORATORY LAPARATOMY - SMALL BOWEL RESECTION RELATED TO BOWEL INJURY, LIKELY BURN INJURY. NINE DAYS LATER ADDITIONAL SURGERY, SMALL BOWEL RESECTION DUE TO BOWEL INJURY (PERFORATION X2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STARZ ENDOSCOPY - AMERCUE INC INSULATED BIPOLAR FORCEP HCZ KARL STORZ GMBH & CO. KG 26176FB DY

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O FX - ELECTROSURGICAL UNIT.| HIGH FREQUENCY CORD VALLEY LAB FORCE