BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 21816680 · Received April 10, 2025

    Report

    Report Number
    1717344-2025-00522
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 26, 2025
    Report Date
    July 3, 2025
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    PMA / PMN Number
    K151649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION: B5, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE ANALYSIS/EVALUATION FOUND THE GENERATOR GAVE ERROR CODES 212, 215, 217 228, AND 302. TROUBLESHOOTING DETERMINED THE CONTROLLER PCBA WAS DEFECTIVE. THE ANALYSIS/EVALUATION FOUND THE MONOPOLAR 1 RECEPTACLE HAD A SELF-ACTIVATION ISSUE. TROUBLESHOOTING DETERMINED THE MONOPOLAR 1 RECEPTACLE WAS DEFECTIVE. IT WAS REPORTED THAT THE UNIT HAD ERROR CODE 212, 215, 217, 228, 302 AND MONOPOLAR 1 AUTO ACTIVATED. THE MONOPOLAR 1 SCREEN WAS AUTO ACTIVATING. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE IN FORMATION 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

    ADDITIONAL INFORMATION: B5, G3, H6. 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 UNIT HAD ERROR CODE 212 AND MONOPOLAR 1 AUTO ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT,

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER PRIOR TO USE, THE UNIT HAD ERROR CODE 212, 215, 217, 228, 302 AND MONOPOLAR 1 AUTO ACTIVATED. ONCE THE MACHINE SWITCHED ON, THE MONOPOLAR 1 SCREEN AUTO ACTIVATING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD ERROR CODE 212 AND MONOPOLAR 1 AUTO ACTIVATED. ONCE THE MACHINE SWITCHED ON, THE MONOPOLAR 1 SCREEN AUTO ACTIVATING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664935 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER VLFT10GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown