BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 18505243 · Received January 12, 2024

    Report

    Report Number
    2182208-2024-00145
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 13, 2023
    Report Date
    July 18, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GEI
    UDI-DI
    10884521750593
    PMA / PMN Number
    K210338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B1, B2 (IR, OTHER), B5, G3, H1 (SERIOUS INJURY), H6 (FDP/IME/IMF CODES) NEW INFORMATION HAS BEEN RECEIVED PERTAINING TO THE EVENT. THIS EVENT HAS BEEN REASSESSED AND THE REPORTABILITY HAS BEEN DETERMINED TO BE A SERIOUS INJURY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, G4 (510K), H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE DEVICE ACTIVATED ON ITS OWN WITHOUT BEING PRESSED AND BEGAN TO BURN PATIENT'S LEG. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. 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

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING LEG VEIN HARVESTING, THE CAUTERY PENCIL WAS LAYING AGAINST PATIENT'S LEG DURING VEIN HARVESTING. SUDDENLY ACTIVATED ON ITS OWN WITHOUT BEING PRESSED AND BEGAN TO BURN PATIENT'S LEG. ACTIVATION BUTTON OR SWITCH STICK IN WAS NOT IN "ON" POSITION. THE PENCIL WAS SWITCHED OUT, THE NEW PENCIL DID NOT MALFUNCTION IN THE SAME WAY. THE PATIENT SUSTAINED TWO BURNS LOCATED AT THE INNER LOWER LEFT LEG AND DORSAL LEFT LOWER LEG. ONE FULL THICKNESS TO THE OPERATIVE LEG THAT WAS EXCISED AND CLOSED PRIMARILY AND ANOTHER THAT WAS PARTIAL THICKNESS THAT WAS LEFT OPEN TO AIR. THE WOUNDS WERE CLOSED PRIMARILY AND WOUND CARE PROVIDED ON THE UNIT. IT DID NOT APPEAR THAT THE WOUNDS DETERIORATED DURING THAT TIME WHICH REQUIRED ESCALATION TO WOUND CARE SPECIALISTS OR ID. FURTHERMORE, ALL PT GOALS THAT WERE SET DURING THE PATIENT'S ADMISSION WERE ACHIEVED AND THE PATIENT DID NOT REQUIRE HOME CARE FOR WOUND CARE SERVICES POST-DISCHARGE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CAUTERY PENCIL WAS LAYING AGAINST PATIENT'S LEG DURING VEIN HARVESTING. SUDDENLY ACTIVATED ON ITS OWN WITHOUT BEING PRESSED AND BEGAN TO BURN PATIENT'S LEG. ACTIVATION BUTTON OR SWITCH STICK IN WAS NOT IN "ON" POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773126 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC, INC. SEP5000 2202017X 10884521750593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O