BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ BOWEL GRASPER

    MDR report key: 2575136 · Received May 9, 2012

    Report

    Report Number
    2575136
    Event Type
    Injury
    Date Received
    May 9, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 4, 2012
    Manufacturer
    KARL STORZ
    Product Code
    GCJ
    Product Problem
    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), FEMALE, DIAGNOSED WITH APPENDICITIS AND ADMITTED TO WFBH FOR A LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2012. DURING THE PROCEDURE A LAPAROSCOPIC BOWEL GRASPER WAS INTRODUCED THROUGH THE INFERIOR PORT IN AN ATTEMPT TO TAKE DOWN SEVERAL ADHESIONS THAT WERE LOCATED AROUND THE AREA OF THE UMBILICUS. ONE-HALF OF THE BOWEL GRASPER BROKE LOOSE AND A PORTION WAS LOST IN THE ABDOMINAL CAVITY. THE SURGEON COMPLETED THE APPENDECTOMY THEN BEGAN TO SEARCH FOR THE BROKEN PIECE OF THE BOWEL GRASPER. AN ADDITIONAL PORT WAS PLACED IN THE LEFT UPPER QUADRANT TO AID IN THE SEARCH FOR THE MISSING PIECE OF INSTRUMENT. THERE WAS DIFFICULTY IN LOCATING THE BROKEN PIECE SO A DECISION WAS MADE TO PLACE A HAND ASSIST PORT. THE HAND ASSIST PORT WAS PLACED IN THE STANDARD FASHION AND THE PIECE OF BROKEN INSTRUMENT WAS FOUND DEEP ON THE PELVIS, THE PIECE WAS REMOVED WITHOUT DIFFICULTY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention HAND PIECE TO GRASPER IS 33121 CLICKLINE