BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 20169472 · Received September 9, 2024

    Report

    Report Number
    1717344-2024-01775
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 18, 2024
    Report Date
    November 19, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    BWA
    UDI-DI
    10884521766662
    PMA / PMN Number
    K874794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. FUNC TIONAL TESTING FOUND THAT THE DEVICE DID NOT ACTIVATE CUT OR COAG WHEN PRESSED. THE DEVICE WAS OPENED AND INSPECTED. THE BLACK INCOMING WIRE HAD DISCONNECTED FROM THE COAG SWITCH ASSEMBLY. THE BLACK WIRE WAS RESTING DIRECTLY NEXT TO THE RED WIRES TERMINAL BUT WAS NOT IN CONTACT, IMAGES HAVE BEEN ATTACHED TO THE COMPLAINT RECORD. TESTING FOUND THAT WHEN BLACK WIRE WAS IN CONTACT WITH THE STATED TERMINAL THE DEVICE WOULD CONTINUALLY ACTIVATE COAG WITHOUT BEING PRESSED. THE BLACK WIRE WAS THEN RESEATED PER THE DEVICE DRAWING AND THE DEVICE WAS FOUND TO FUNCTION PROPERLY, ACTIVATING CUT AND COAG WHEN PRESSED, NO SELF-ACTIVATION PRESENT. IT WAS REPORTED THAT THE DEVICE WAS SELF ACTIVATING AND HAS FOOT SWITCH FAILURE. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: VLFT10GEN, VLFT10GEN FT SERIES ENERGY PLATFORMX1, (SERIAL#UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE PEDAL WAS PLUGGED IN AND IT JUST WENT OFF LIKE IT WAS BEING USED - NON STOP. THEY HAD TO UNPLUG IT AND PLUG IT BACK IN TO GET IT TO STOP. THEN IT DID NOTHING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020846 VALLEYLAB UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES BWA COVIDIEN MFG DC BOULDER E6008L 413329 10884521766662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown