BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC BOWEL GRASPER

    MDR report key: 2287955 · Received October 6, 2011

    Report

    Report Number
    2287955
    Event Type
    Injury
    Date Received
    October 6, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 26, 2011
    Manufacturer
    KARL STORZ
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A (B)(6) MALE WHO WAS ADMITTED TO THE MEDICAL CENTER FOR ACUTE ONSET OF ABDOMINAL PAIN ON (B)(6) 2011. THE PT WAS DIAGNOSED WITH AN APPENDICITIS AND UNDERWENT LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2011. DURING THE PROCEDURE, ONE JAW OF THE LAPAROSCOPIC BOWEL GRASPER DISLODGED DURING USE INSIDE THE PT. THE JAW COMPLETELY SEPARATED FROM THE DEVICE AND WAS REMOVED FROM THE ABDOMEN BY THE SURGEON AT THE TIME OF THE SURGERY. THE EVENT CAUSED A SHORT DELAY IN THE PROCEDURE BUT NO KNOWN HARM TO THE PT. THE GRASPER HAD BEEN USED SEVERAL TIMES DURING THE PROCEDURE ON APPENDIX AND BOWEL TISSUE BEFORE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC BOWEL GRASPER LAPAROSCOPIC BOWEL GRASPER GCJ KARL STORZ 33300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other HANDPIECE FOR THE GRASPER MODEL #33121