BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG

    MDR report key: 11338144 · Received February 17, 2021

    Report

    Report Number
    1423507-2021-00005
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 15, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    UDI-DI
    10885403154805
    PMA / PMN Number
    K971540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP (B)(4). THE COMPLAINT PRODUCT WAS RETURNED, AND AN EVALUATION WAS PERFORMED. THE PRODUCT 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 PRODUCT WAS RETURNED FOR EVALUATION. WE WERE ABLE TO CONFIRM THAT THE LOT NUMBER ON THE DEVICE WAS 110882. THIS LOT NUMBER WAS SOLD TO CAREFUSION IN (B)(6) 2018. BASED ON THIS INFORMATION, THE PRODUCT HAS BEEN IN USE FOR APPROXIMATELY TWO YEARS AND TWO MONTHS. UPON OUR EVALUATION OF THE PRODUCT, IT WAS NOTED THE DEVICE SHOWED SIGNIFICANT SIGNS OF WEAR AND TEAR. THIS WEAR AND TEAR OCCURRED OVER THE TWO YEAR AND TWO-MONTH TIME PERIOD IT WAS IN USE. THIS PRODUCT HAS A RECOMMENDATION OF TWENTY USES. EXTENSIVE BENDING AT THE INSTRUMENT END WILL CAUSE THE WIRES TO WEAR OVER TIME AND SHORT OUT INTERNALLY. THE PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE EXTENSIVE USE OVER TWO YEARS AND TWO MONTHS THAT CAUSED WEAR AND TEAR TO THE INTERNAL WIRING. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) DID NOT IDENTIFY AND ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I RECEIVED A CALL FROM A CUSTOMER WHO STATED THE CORD BURNED COMPLETELY THROUGH AT THE BLUE END THAT CONNECTS TO INSTRUMENT DURING SURGERY. DOCTOR IS CONCERNED THIS COULD BE A BAD LOT. MATERIAL NO.: 88-9199; LOT NO.: 110882. DOE: (B)(6) 2021. NO INJURIES. 15FEB2021 ADDITIONAL INFORMATION: CUT/COAG WAS SET AT 30/30. SURGEON WAS USING CORD AND DISPOSABLE LAPAROSCOPIC HOOK AUTO SUTURE SCISSORS LAPAROSCOPIC CHOLECYSTECTOMY. NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    PR # (B)(4) - 04FEB2021 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

    HOLD FOR MARLO 2.17PER EMAIL: EVENT DESCRIPTION PER ATTACHED EMAIL STATES: I RECEIVED A CALL FROM A CUSTOMER WHO STATED THE CORD BURNED COMPLETELY THROUGH AT THE BLUE END THAT CONNECTS TO INSTRUMENT DURING SURGERY. DOCTOR IS CONCERNED THIS COULD BE A BAD LOT. MATERIAL NO.: 88-9199; LOT NO.: 110882. DOE: (B)(6) 2021. NO INJURIES. 15FEB2021 ADDITIONAL INFORMATION: CUT/COAG WAS SET AT 30/30. SURGEON WAS USING CORD AND DISPOSABLE LAPAROSCOPIC HOOK AUTO SUTURE SCISSORS LAPAROSCOPIC CHOLECYSTECTOMY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233885 UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC 88-9199 110882 10885403154805

    Patients

    Seq Age Sex Outcome Treatment
    1