BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CUTTING LOOP

    MDR report key: 2080426 · Received April 22, 2011

    Report

    Report Number
    1825146-2011-00021
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 22, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION NOTING THE CUSTOMER HAS INDICATED THE DEVICE WILL BE RETURNED. THE CUSTOMER IS CONCERNED THAT A PORTION OF THE CUTTING LOOP HAS REMAINED INSIDE THE PATIENT'S UTERUS AND AN X-RAY HAS PERFORMED, HAVE DONE CHECKS AND SEARCHES AND HAVE NOT BEEN ABLE TO LOCATE THE CUTTING LOOP. UPON RECEIPT OF THE DEVICE AN EVALUATION WILL BE PERFORMED TO DETERMINE HOW MUCH OF THE TIP IS NO LONGER PRESENT ALONG WITH CONTACT WITH PERSONNEL AT THE FACILITY TO OBTAIN INFORMATION CONCERNING THE SEPARATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE CUTTING LOOP CAME OFF (MAY HAVE BURNED OR CRACKED OFF). CUSTOMER IS CONCERNED THIS MAY NOW STILL BE IN THE PATIENT. LOOP OFF DIATHERMY LOST WHILST IN SITU IN UTERUS. NOT ABLE TO ACCOUNT FOR MISSING LOOP-XRAY AND ALL CHECKS/SEARCHES DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CUTTING LOOP GEI UNIT, ELECTROSURGICAL AND ACCESSORIES GEI COOK UROLOGICAL INC NA U1997365

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR