BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG

    MDR report key: 10314991 · Received July 23, 2020

    Report

    Report Number
    1423507-2020-00024
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 17, 2020
    Report Date
    October 26, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    1697551 FOLLOW UP. THE COMPLAINT PRODUCT WAS RETURNED, AND AN EVALUATION WAS PERFORMED. THE INSTRUMENT AT THE TIME OF MANUFACTURING, WOULD HAVE CONFORMED TO ALL SPECIFICATIONS FOR THE PRODUCTION. THE ROOT CAUSE FOR THE REPORTED ISSUE IS MOST LIKELY DUE TO WEAR DURING MAINTENANCE/PROCESSING, EXCESSIVE USE AND STERILIZATION, AND APPEARS TO HAVE REACHED END OF LIFE. THE LOT NUMBER ON THE DEVICE IS 104091, WHICH MEANS THAT IT WAS MANUFACTURED IN AUGUST OF 2017. UPON EVALUATION, OF THE PRODUCT, IT WAS NOTED THE DEVICE SHOWED SIGNIFICANT SIGNS OF WEAR AND TEAR THAT OCCURRED OVER THREE YEARS. THIS PRODUCT HAS A RECOMMENDATION OF TWENTY USES. THE EXTENSIVE BENDING AT THE INSTRUMENT END WILL CAUSE THE WIRES TO WEAR OVER TIME AND SHORT OUT INTERNALLY. THERE WERE NO ISSUES FOUND IN THE DEVICE HISTORY RECORD THAT INDICATED ANY ISSUES WITH THESE MANUFACTURING LOTS. THE PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE EXTENSIVE USE OVER THREE YEARS THAT CAUSED WEAR AND TEAR TO THE INTERNAL WIRING. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS. SEE H10.

    Description of Event or Problem · 0

    EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THANK YOU FOR YOUR TIME REVIEWING THE PRODUCT INCIDENT WITH THE MONOPOLAR CORD REF # (B)(4). DURING A PROCEDURE THIS MORNING THE CORD STARTED SMOKING AND THEN A SPARK WAS SEEN NEAR THE BLUE TIP FROM THE CORD. DURING ROBOTIC TAH IN OR # 5, RESIDENT NOTED THAT THERE WAS SMOKE COMING FROM THE BLUE TIP OF THE NON-DISPOSABLE GREY MONOPOLAR BOVIE CORD AND THEN SHE NOTED A QUICK SPARK FROM THE BLUE TIP OF THE CORD. CORD WAS QUICKLY REMOVED FROM THE SURGICAL AREA AND UNPLUGGED. NO DAMAGE TO DRAPES/PATIENT NOTED. CORD TAKEN TO FRONT DESK. A NEW LAPAROSCOPIC TRAY WAS OPENED TO OBTAIN ANOTHER MONOPOLAR CORD FOR SURGERY. NO FURTHER INCIDENT NOTED. CAN YOU CONFIRM/PROVIDE BATCH NUMBER? UNKNOWN. CONFIRM NO PATIENT/STAFF INJURY. NO INJURIES. DID COURSE TREATMENT CHANGED DUE TO EVENT? NO. WHAT WAS THE PATIENT'S OUTCOME? NO ADVERSE OUTCOMES. WAS THE PROCEDURE COMPLETED AS PLANNED? YES, A SPARE BOVIE CORD WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(6) 2020 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THANK YOU FOR YOUR TIME REVIEWING THE PRODUCT INCIDENT WITH THE MONOPOLAR CORD REF # (B)(4). DURING A PROCEDURE THIS MORNING THE CORD STARTED SMOKING AND THEN A SPARK WAS SEEN NEAR THE BLUE TIP FROM THE CORD. DURING ROBOTIC TAH IN OR # 5, RESIDENT NOTED THAT THERE WAS SMOKE COMING FROM THE BLUE TIP OF THE NON-DISPOSABLE GREY MONOPOLAR BOVIE CORD AND THEN SHE NOTED A QUICK SPARK FROM THE BLUE TIP OF THE CORD. CORD WAS QUICKLY REMOVED FROM THE SURGICAL AREA AND UNPLUGGED. NO DAMAGE TO DRAPES/PATIENT NOTED. CORD TAKEN TO FRONT DESK. A NEW LAPAROSCOPIC TRAY WAS OPENED TO OBTAIN ANOTHER MONOPOLAR CORD FOR SURGERY. NO FURTHER INCIDENT NOTED. CAN YOU CONFIRM/PROVIDE BATCH NUMBER? UNKNOWN. CONFIRM NO PATIENT/STAFF INJURY. NO INJURIES. DID COURSE TREATMENT CHANGED DUE TO EVENT? NO. WHAT WAS THE PATIENT'S OUTCOME? NO ADVERSE OUTCOMES. WAS THE PROCEDURE COMPLETED AS PLANNED? YES, A SPARE BOVIE CORD WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781997 UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other