BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CLIP APPLIER CARTRIDGE

    MDR report key: 1286779 · Received January 7, 2009

    Report

    Report Number
    2027111-2009-00002
    Event Type
    Other
    Date Received
    January 7, 2009
    Date of Event
    December 5, 2008
    Report Date
    January 6, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. WE HAVE REVIEWED THE DEVICE HISTORY RECORD OF THIS DEVICE AND FOUND NO DEVIATIONS OR DISCREPANCIES IN OUR STANDARD MFG AND TESTING PROCEDURES. THE CER WAS DELAYED BY THE HOSP PENDING A REVIEW OF THE CASE WITH THE SURGEON. THE HOSP DID NOT REPORT THIS INCIDENT TO THE FOREIGN AUTHORITY AS THE INCIDENT COULD NOT BE CONFIRMED TO BE A RESULT OF A DEVICE FAILURE. THEREFORE, WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "AFTER THE PROCEDURE, THERE WERE BLEEDINGS, THE PT HAD A SECOND PROCEDURE FOR BILIARY PERITONITIS AND CLOSING AGAIN THE CYSTIC CANAL. THE SURGEON SAID IT WAS LINKED TO A CLIP FALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CLIP APPLIER CARTRIDGE NONE GDO APPLIED MEDICAL RESOURCES CORP. CA001 1067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention