BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 24649242 · Received March 20, 2026

    Report

    Report Number
    1717344-2026-00410
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 14, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    10884521516328
    PMA / PMN Number
    K151649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: VLFT10GEN, VLFT10GEN FT SERIES ENERGY PLATFORMX1 (SERIAL# (B)(6)). 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 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

    IT WAS REPORTED THAT DURING GENDER AFFIRMING BILATERAL MASTECTOMY WITH FREE NIPPLE GRAFT, THERE WERE 2 UNITS IN USE. EACH UNIT HAD A NON-MEDTRONIC PEN PLUGGED INTO THE MONOPOLAR PORT. EACH UNIT ALSO HAD A NON-MEDTRONIC REM PAD PLUGGED INTO THE REM PAD PORT. THE NON-MEDTRONIC REM PAD WAS PLACED ON THE PATIENTS' UPPER THIGH. THE MONOPOLAR SETTINGS WERE SET TO 60/60. ACCORDING TO THE NURSE, THE PATIENT SUDDENLY STARTED TO BRADY DOWN WHILE USING BOTH HANDPIECES. ANESTHESIOLOGIST ASKED THEM TO STOP WHILE TRYING TO FIGURE OUT WHAT WAS GOING ON. THE PATIENT ENDED UP IN ASYSTOLE AND CHEST COMPRESSIONS HAD TO BE PERFORMED. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED AND THE PATIENT WAS BROUGHT TO THE PACU (POST-ANESTHESIA CARE UNIT) EXTUBATED. THE SURGICAL TIME AND HOSPITALIZATION WERE EXTENDED, AND THE PATIENT WAS TRANSFERRED TO THE ICU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING GENDER AFFIRMING BILATERAL MASTECTOMY WITH FREE NIPPLE GRAFT, THERE WERE 2 UNITS IN USE. EACH UNIT HAD A NON-MEDTRONIC PEN PLUGGED INTO THE MONOPOLAR PORT. EACH UNIT ALSO HAD A NON-MEDTRONIC REM PAD PLUGGED INTO THE REM PAD PORT. THE NON-MEDTRONIC REM PAD WAS PLACED ON THE PATIENT'S UPPER THIGH. THE MONOPOLAR SETTINGS WERE SET TO 60/60. ACCORDING TO THE NURSE THE PATIENT SUDDENLY STARTED TO BRADY DOWN WHILE USING BOTH HANDPIECES. ANESTHESIOLOGIST ASKED THEM TO STOP WHILE TRYING TO FIGURE OUT WHAT WAS GOING ON. THE PATIENT ENDED UP IN ASYSTOLE AND CHEST COMPRESSIONS HAD TO BE PERFORMED. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED AND THE PATIENT WAS BROUGHT TO THE PACU (POST-ANESTHESIA CARE UNIT) EXTUBATED. THE SURGICAL TIME AND HOSPITALIZATION WAS EXTENDED AND PATIENT IS NOW IN THE ICU. THE HOSPITAL KEPT THE PATIENT FOR OBSERVATION OVERNIGHT RELATED TO THE ASYSTOLE EVENT. THEY WERE DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430016 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN VLFT10GEN 10884521516328

    Patients

    Seq Age Sex Outcome Treatment
    1