BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAUTERY HOOK 5MM

    MDR report key: 2739087 · Received September 1, 2012

    Report

    Report Number
    1043582-2012-00100
    Event Type
    Injury
    Date Received
    September 1, 2012
    Date of Event
    June 25, 2012
    Report Date
    August 31, 2012
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GENERAL PRODUCT AND MANUFACTURING PROCESS WAS REVIEWED AS ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION. A FINAL DETERMINATION REGARDING THIS INCIDENT COULD NOT BE DETERMINED. POTENTIAL CAUSES EVALUATED: MISSING WELDS: NO MISSING WELDS WERE FOUND. EACH PART IS 100% INSPECTED PRIOR TO WELDING. EACH PART IS 100% INSPECTED UPON RETURN OF WELDING. WEAK WELDS: EIGHT UNITS FROM EACH LOT ARE SENT TO THE LAB FOR LEAK TESTING AND TENSILE PULL TESTING. THE HOOK ASSEMBLIES ARE TESTED TO FAILURE. IF FAILURE OCCURS PRIOR TO SPECIFICATION LIMIT, THE LOT WILL BE REJECTED. NO OBJECTIVE EVIDENCE PROVIDED TO SUPPORT WEAK WELDS BASED ON VISIBLE EXAMINATION OR PHYSICAL TEST. MISUSE BY THE CUSTOMER: CANNOT BE CONFIRMED, THE COMPLAINT INDICATED THAT THE UNIT TWISTED OFF NO CLARIFICATION WAS PROVIDED. OTHER: IT WAS SPECULATED THAT TRAYS COULD POSSIBLY CONTRIBUTE TO WEAK WELDS; HOWEVER, THIS WAS NEVER CONFIRMED, SUSPECT TRAYS WERE REMOVED FROM SERVICE AND REPLACED.

    Description of Event or Problem · 1

    A VOLUNTARY REPORT WAS RECEIVED REGARDING AN ADVERSE EVENT RELATED TO A MICROTEK MANUFACTURED MEDICAL DEVICE. THE REPORT, (B)(4), CONTAINED THE FOLLOWING INFORMATION REGARDING THE EVENT. NO PATIENT INFORMATION WAS PRESENTED OR ABLE TO BE RETRIEVED. "VOLUN (B)(6) 2012: PATIENT TAKEN TO OPERATING ROOM FOR LAPAROSCOPIC CHOLECYSTECTOMY BY DOCTOR DURING USE OF ELECTROCAUTERY PROBE, THE TIP OF ELECTROCAUTERY PROBE TWISTED OFF FELL OFF THE CAUTERY INSTRUMENT AND WAS NOT EASILY IDENTIFIABLE BUT IT WAS THE IN PATIENT'S ABDOMEN. FLUOROSCOPY WAS BROUGHT IN AND THE TIP OF THE PROBE WAS IDENTIFIED BEHIND THE LIVER. EXTENSIVE EXPLORATION WAS NECESSARY AND AFTER 2.5 HRS THE PROBE WAS FINALLY IDENTIFIED AND IT WAS REMOVED THROUGH THE UMBILICAL PORT ALONG WITH THE GALLBLADDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY HOOK 5MM NAY - CAUTERY HOOK NAY MICROTEK MEDICAL, INC. C11283

    Patients

    Seq Age Sex Outcome Treatment
    1