BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3020572 · Received March 20, 2013

    Report

    Report Number
    2027111-2013-00078
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 20, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE - "THE SURGEON WAS PERFORMING A LAP CHOLE. HE FIRED 3 CLIP AND EVERYTHING WORKED WELL. WHEN HE USED AGAIN THE CLIP APPLIER ON THE CYSTIC DUCT. IT STOPPED WORKING AND NO CLIP IN THE JAWS. THIS CAUSED SOME PROBLEMS TO HIM BECAUSE THE CYSTIC DUCT WAS QUITE SHORT AND IT WAS "DAMAGED" FROM THE JAWS SQUEEZED ON IT, SO HE WAS VERY NERVOUS. AT THE END HE USED ANOTHER CA090 (DON'T KNOW LOT NUMBER). HE DIDN'T USED THE JAW TO SKELETRIZE THE DUCT, NO APPLICATION OF CLIP ON A METALLIC CATHETER, NO APPLICATION OF CLIP ONTO ANOTHER CLIP." TYPE OF INTERVENTION: "NOTHING BUT THE SURGEON REPORTS THAT HE NEEDED TO WORK A LOT TO CLOSE THE DUCT." PATIENT STATUS: "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116190 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1184664

    Patients

    Seq Age Sex Outcome Treatment
    1 OUR TROCAR (HE IS USING OUR KIT)