BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T DISSECTOR "L" HOOK

    MDR report key: 33748 · Received May 14, 1996

    Report

    Report Number
    33748
    Event Type
    Injury
    Date Received
    May 14, 1996
    Date of Event
    May 8, 1996
    Report Date
    May 13, 1996
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FHB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT TIP "L" HOOK BROKE OFF INSIDE PT DURING LAPAROSCOPIC PROCEDURE; X-RAY VERIFIED TIP INSIDE PT; RE-OPENED PT TO REMOVE TIP. MFG DATE CODE, KP = 10/95 (IN WARRANTY). PROCEDURE REQUIRED APPROX 5 HRS TO CONDUCT, INCLUDING RETRIEVAL OF FOREIGN BODY. POST-OP RECOVERY UNEVENTFUL TO THIS POINT. CAUSATION OF FBO UNDETERMINED AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T DISSECTOR "L" HOOK T DISSECTOR "L" HOOK FHB KARL STORZ ENDOSCOPY-AMERICA, INC. 28775UF

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention