BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA LIFESCIENCES COMPANY

    MDR report key: 1673418 · Received April 30, 2010

    Report

    Report Number
    MW5015765
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    J JAMNER SURGICAL INSTRUMENTS INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PIECE OF A SURGICAL INSTRUMENT (A DUCK BILL GRASPER) BROKE OFF INSIDE OF THE PT DURING A PROCEDURE. WE NOTICED THE INSTRUMENT WAS BROKEN AND BEGAN TO SEARCH THE FLOOR, DRAPES AND LOOK IN THE BODY CAVITY WITH THE LAPAROSCOPIC CAMERA. RADIOLOGY XRAY WITH C-ARM AND THE ITEM WAS LOCATED AND THEN TAKEN OUT WITH A LAPAROSCOPIC INSTRUMENT BY PHYSICIAN, NO PART OF THE INSTRUMENT WAS LEFT BEHIND INSIDE OF THE PT. WE FINISHED THE BILATERAL INGUINAL HERNIA REPAIR WITH NO OTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA LIFESCIENCES COMPANY DUCK BILL GRASPER GCJ J JAMNER SURGICAL INSTRUMENTS INC 600-110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention