BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD

    MDR report key: 8384385 · Received March 2, 2019

    Report

    Report Number
    1717344-2019-00269
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    October 1, 2018
    Report Date
    March 1, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    20884521062082
    PMA / PMN Number
    K110268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INCIDENT SAMPLE WAS SENT TO BIOMEDICAL INNOVATIONS (BMED) FOR EVALUATION, HOWEVER NO FAILURE MODE WAS IDENTIFIED. THE DHR INDICATED ALL OPERATIONS WERE COMPLETED AND PROPERLY SIGNED OFF PRIOR TO LOT RELEASE FOR SHIPMENT. REVIEW OF BMED NONCONFORMANCE INVESTIGATIONS (2015 ¿ PRESENT) AND THE OLDER NONCONFORMING MATERIAL REPORT RECORDS (2012 ¿ 2015) FOUND NO INTERNAL ISSUES SIMILAR TO THAT REPORTED FOR THIS COMPLAINT. VISUAL EXAMINATION OF THE STORZ CABLE LIGASURE PLUG AND THE TWO CONDUCTOR CABLES BETWEEN THE PLUG AND THE STORZ CABLE, FOUND NO ANOMALIES. NO EVIDENCE OF CABLE WORKMANSHIP DEFECTS WAS FOUND. INSPECTION OF THE STORZ CONNECTOR FOUND DAMAGE TO THE OVERMOLDED PLASTIC IN THE AREA ABOVE AND TO THE OUTSIDE OF THE PIN 1 RECEPTACLE. THE DAMAGE APPEARS TO BE MELTING OF THE CONNECTOR PLASTIC DUE TO EXCESSIVE HEAT AND IS CONSISTENT WITH OTHER RETURNED STORZ CABLES EXHIBITING SIMILAR DAMAGE TO VARYING DEGREES IN THE PIN 1 AREA. DUE TO THE CONNECTOR DAMAGE PRESENT AND TO ENSURE PERSONNEL SAFETY, THE NORMAL PRODUCTION CONTINUITY/HIPOT TEST WAS NOT PERFORMED. INSTEAD, A MANUAL CHECK OF THE CABLE CONTINUITY WAS PERFORMED USING A FLUKE 70 III MULTIMETER. RESULTS OF THE CHECK FOUND EXPECTED INSTANCES OF CONTINUITY TO STILL BE PRESENT IN THE CABLE, DESPITE THE DAMAGE TO THE STORZ CONNECT. OVERALL, THIS INVESTIGATION FOUND THAT THE CABLES SHIPPED BY CEA IN LOT X312 COMPLETED REQUIRED TESTING AND INSPECTIONS, AND MET SPECIFIED REQUIREMENTS. A SOURCE/CAUSE FOR THE EXCESSIVE HEAT THAT RESULTED IN THE MELTED CONNECTOR PLASTIC CANNOT BE DETERMINED. BMED DID NOT FIND ANY EVIDENCE THAT THEY CAUSED THE COMPLAINT ISSUE. ROOT CAUSE CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CABLE WAS BURNT BUT NO FLAME AT THE CONNECTOR THAT PLUGS INTO THE STORZ RESECTOSCOPE TO CONNECT TO OUR GENERATOR. ANOTHER CABLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177816 FORCETRIAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER FT0021S X312X 20884521062082

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR