BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG

    MDR report key: 17320284 · Received July 13, 2023

    Report

    Report Number
    1423507-2023-00094
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 16, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    UDI-DI
    10885403154805
    PMA / PMN Number
    K971540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP THE COMPLAINT PRODUCT WAS RETURNED, AND AN EVALUATION WAS PERFORMED. THE RETURNED DEVICE WAS REVIEWED AND WAS CONFIRMED TO HAVE SIGNS OF SIGNIFICANT WEAR AND TEAR. THE LOT NUMBER WAS CONFIRMED TO BE 100435 WHICH WAS SOLD TO CAREFUSION/BD IN 2017. THIS DEVICE IS ONLY VALIDATED FOR 20 STERILIZATIONS/USES. 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. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    (B)(4). 28JUN2023 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT 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 · 0

    VERBATIM: CUSTOMER REPORTED THE CORD STARTED TO CHANGE TO A GLOWING ORANGE COLOR. THE END THAT CONNECTS INTO THE INSTRUMENT THAT LEADS TO THE FLEXIBLE PORTION OF THE HUB ALSO NEAR GRAY CORD WHERE CORD STOPS AT BLUEISH CONNECTER STARTED TO GLOW ORANGE. THE CUSTOMER REPORTS THAT THEY LEFT CORD IN BIOHAZARD BAG. (B)(6) 2023 ¿ WHAT IS THE MATERIAL NUMBER? 88-9199 ¿ WHAT IS THE LOT NUMBER? 100435 ¿ WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO ¿ PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. NO HARM OR INJURY TO PATIENT ¿ DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? YES ¿ ATTACHED TO THE EMAIL ¿ IS THE PRODUCT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? YES ¿ PLEASE PROVIDE DATE OF INCIDENT. (B)(6) 2023. ADDITIONAL INFORMATION: YES THE CORD CHANGED TO A GLOWING ORANGE COLOR BECAUSE IT GOT TOO HOT. THE CORD STARTED TO GLOW ORANGE IN COLOR, BUT ONCE THE CORD SEPARATED, IT WENT BACK TO THE ORIGINAL GREY COLOR. NO FURTHER INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 0

    VERBATIM: CUSTOMER REPORTED THE CORD STARTED TO CHANGE TO A GLOWING ORANGE COLOR. THE END THAT CONNECTS INTO THE INSTRUMENT THAT LEADS TO THE FLEXIBLE PORTION OF THE HUB ALSO NEAR GRAY CORD WHERE CORD STOPS AT BLUEISH CONNECTER STARTED TO GLOW ORANGE. THE CUSTOMER REPORTS THAT THEY LEFT CORD IN BIOHAZARD BAG. WED 06/28/2023 ¿ WHAT IS THE MATERIAL NUMBER? 88-9199 ¿ WHAT IS THE LOT NUMBER? 100435 ¿ WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO ¿ PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. NO HARM OR INJURY TO PATIENT ¿ DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? YES ¿ ATTACHED TO THE EMAIL. ¿ IS THE PRODUCT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? YES. ¿ PLEASE PROVIDE DATE OF INCIDENT. (B)(6) 2023. 07JUL2023 ADDITIONAL INFORMATION: YES THE CORD CHANGED TO A GLOWING ORANGE COLOR BECAUSE IT GOT TOO HOT. THE CORD STARTED TO GLOW ORANGE IN COLOR, BUT ONCE THE CORD SEPARATED, IT WENT BACK TO THE ORIGINAL GREY COLOR. NO FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840791 UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC 88-9199 100435 10885403154805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other