BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE 10 FEET

    MDR report key: 5040113 · Received August 28, 2015

    Report

    Report Number
    2523190-2015-00071
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 3, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KNF
    PMA / PMN Number
    K932456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    9/21/2015 INTEGRA INVESTIGATION COMPLETED. METHOD : FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: ISSUED (B)(4) 2013 FOR NONCONFORMING PRODUCT. HEALTH HAZARD EVALUATION HISTORY: HHE-926 EFFECTIVE (B)(4) 2010. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED THE CORD CAUGHT FIRE AT THE BOX. (B)(6) 2015 CUSTOMER REPORTS THAT THE SURGEON WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS IN USE 2-3-MINUTES BEFORE THE CORD BEGAN TO SPARK AND SMOKE AT THE ADAPTOR. THE DOCTOR WAS CUTTING THE GALLBLADDER WITH THE J HOOK. THE CABLE WAS CONNECTED TO THE CONMED ESU SYSTEM 5000, SN (B)(4) ON ONE END AND THE J HOOK ON THE OTHER END. NO HARM TO ANYONE.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE CORD CAUGHT FIRE AT THE BOX. ON (B)(6) 15 CUSTOMER REPORTS THAT THE SURGEON WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS IN USE 2-3-MINUTES BEFORE THE CORD BEGAN TO SPARK AND SMOKE AT THE ADAPTOR. THE DOCTOR WAS CUTTING THE GALLBLADDER WITH THE J HOOK. THE CORD FELL IN THE FLOOR AND THE NURSE STEPPED ON IT TO PUT IT OUT. THE CABLE WAS CONNECTED TO THE CONMED ESU SYSTEM 5000, SN (B)(4) ON ONE END AND THE J HOOK ON THE OTHER END. NO HARM TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572407 MONOPOLAR CABLE 10 FEET ELECTROSURGICAL COAGULATION KNF INTEGRA YORK, PA INC. 221-1110

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other