BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 24051406 · Received January 13, 2026

    Report

    Report Number
    8020045-2026-00001
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    October 3, 2025
    Report Date
    March 25, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    19005531595976
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS NEITHER THE CONCERNED LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO THE DATE OF THIS REPORT NO INVESTIGATION COULD BE CONDUCTED. SO FAR, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENT. WE HAVE REQUESTED THE INVOLVED DEVICE AND ALSO THE CONCERNED LOT NUMBER FROM THE INITIAL REPORTER. ONCE ANY FURTHER INFORMATION WILL BECOME AVAILABLE WE WILL PROVIDE A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CONCERNED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. WE HAVE RECEIVED 15 SAMPLES IN ORIGINAL CLOSED POUCHES OF THE CLAIMED LOT NUMBER 250728-2402. ALL RETURNED CUSTOMER SAMPLES WERE INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 5 SAMPLES OUT OF THE RETURNED CUSTOMER POUCHES. ELECTRICALLY TESTS WERE PERFORMED ON 5 CUSTOMER SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION BUT NONE HAS BEEN RECEIVED. IT IS THEREFORE UNCLEAR WHETHER THE REQUIREMENTS SPECIFIED IN THE IFU HAVE BEEN FOLLOWED. THE IFU STATES: "PRODUCT LIMITATIONS FOR NEUTRAL ELECTRODES FOR ADULTS: RESTRICT THE DURATION OF ACTIVATION TO A MAXIMUM OF 60 SECONDS WITHIN EACH 2 MINUTE PERIOD. SELECTION AND PREPARATION OF THE PLACEMENT SITE: SELECT A CONVEX SKIN SURFACE THAT IS MUSCULAR OR WELL SUPPLIED WITH BLOOD AND AS CLOSE AS POSSIBLE TO THE SURGICAL SITE, BUT, IF POSSIBLE, AT LEAST 15 CM AWAY FROM IT: ON ADULTS PREFERABLY ON THE UPPER ARM OR UPPER THIGH. ALIGN THE NEUTRAL ELECTRODE SO THAT ONE OF ITS LONG SIDES IS CLOSEST TO THE SURGICAL SITE. FOR ELECTROSURGICAL GENERATORS, WHICH ARE EQUIPPED WITH THE SYSTEM TO MONITOR THE NEUTRAL ELECTRODE CONTACT QUALITY AS WELL AS A SYSTEM TO MONITOR AN EVEN CURRENT DISTRIBUTION ACROSS BOTH CONDUCTIVE SURFACES OF THE NEUTRAL ELECTRODE, THE SPLIT ELECTRODE MUST BE ALIGNED SO THAT THE SPLIT IS POINTING TOWARDS THE SURGICAL SITE, OTHERWISE ALARMS MAY BE TRIGGERED. APPLY THE NEUTRAL ELECTRODE TO THE PREPARED AREA OF SKIN, STARTING WITH ONE CORNER, AND APPLYING EVEN PRESSURE OVER THE ENTIRE SURFACE WITHOUT STRETCHING THE SKIN OR THE ELECTRODE. PREVENT THE EMERGENCE OF AIR BUBBLES OR SKIN FOLDS BENEATH THE ELECTRODE. GENTLY RUB YOUR HAND OVER THE ELECTRODE TO ENSURE GOOD CONTACT OF THE ENTIRE ADHESIVE SURFACE TO THE SKIN." NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM.

    Description of Event or Problem · 0

    ON (B)(6) 2025 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED AT AN UNKNOWN USER SITE IN THE UK. A MONITORING DISPERSIVE ELECTRODE (MODEL SKINTACT WR21A30) AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED " THE BURN WAS DISCOVERED AT THE ATTACHMENT OF THE CABLE CONNECTION TO THE DIATHERMY PAD AT THE END OF THE PROCEDURE WHEN THE DIATHERMY PAD WAS REMOVED FROM THE PATIENT'S LEG. THE PATIENT'S LEGS WERE IN LITHOTOMY DURING THE PROCEDURE. THE DIATHERMY MACHINE HAD ALARMED TWICE DURING THE PROCEDURE. THE SCRUB PRACTITIONER PRESSED THE PAD DOWN TO MAKE SURE CONTACT WAS MAINTAINED. WR21A30." WE HAVE REQUESTED FRUTHER INFORMATION BUT NO INFORMATION ABOUT THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENT, HOW THE SKIN WAS PREPARED, IF AND HOW THE INJURY WAS TREATED AFTERWARDS HAVE BEEN DISCLOSED TO US SO FAR.

    Description of Event or Problem · 0

    ON (B)(6) 2025 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A ROBOTIC HYSTERECTOMY, SALPINGO-OOPHORECTOMY & BIOPSY PROCEDURE WAS PERFORMED AT AN UNKNOWN USER SITE IN THE UK. A MONITORING DISPERSIVE ELECTRODE (MODEL SKINTACT WR21A30) AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED " THE BURN WAS DISCOVERED AT THE ATTACHMENT OF THE CABLE CONNECTION TO THE DIATHERMY PAD AT THE END OF THE PROCEDURE WHEN THE DIATHERMY PAD WAS REMOVED FROM THE PATIENT'S LEG. THE PATIENT'S LEGS WERE IN LITHOTOMY DURING THE PROCEDURE. THE DIATHERMY MACHINE HAD ALARMED TWICE DURING THE PROCEDURE. THE SCRUB PRACTITIONER PRESSED THE PAD DOWN TO MAKE SURE CONTACT WAS MAINTAINED. WR21A30." WE HAVE REQUESTED FOR FURTHER INFORMATION AND HAVE BEEN INFORMED THAT THE PROCEDURE LASTED FOR ABOUT 2HOURS AND 20 MINUTES. IN A FANNIN COMPLAINT FORM IT WAS SPECYFYED "PATIENT RECEIVED BURN TO LEG FROM DIATHERMY PAD DURING OPERATION. THIS WAS DISCOVERED WHEN THE PAD WAS REMOVED FROM THE PATIENT'S LEG AT THE END OF THE PROCEDURE. THE DIATHERMY MACHINE ALARMED TWICE DURING THE PROCEDURE INDICATING A LOSS OF CONTACT OF THE PAD. THE SCRUB PRACTITIONER CHECKED THAT THE PAD WAS STILL IN CONTACT WITH THE SKIN BY PRESSING DOWN ON THE STERILE DRAPES AT THE PAD SITE. THE MACHINE RESUMED NORMAL FUNCTION. THE SCRUB PRACTITIONER DID NOTE A BURNING SMELL DURING THE PROCEDURE BUT THIS WAS ATTRIBUTED TO THE USUAL SMELL OF SMOKE THROUGH THE USE OF DIATHERMY BY THE ADVANCED SCRUB PRACTITIONER WHO WAS ASSISTING." "SURGICAL TEAM INFORMED IMMEDIATELY FOLLOWING REMOVAL OF THE DIATHERMY PAD AT THE END OF THE PROCEDURE. SURGEON CONTACTED PLASTIC SURGERY TEAM FOR ASSESSMENT AND TREATMENT OF THE BURN ONCE THE PATIENT HAD LEFT THEATRE. OINTMENT APPLIED TO THE BURN AS ADVISED BY THE PLASTIC SURGEON. BAND 7 SENIOR CHARGE NURSE INFORMED. THE COMPANY WHO PROVIDES THE DIATHERMY MACHINE WERE CONTACTED AND THE REP CAME THE SAME DAY TO REMOVE THE DIATHERMY MACHINE TO BE SENT BACK TO THE COMPANY FOR INVESTIGATION AND PROVIDED A REPLACEMENT MACHINE. DIATHERMY PADS WITH THE SAME LOT NUMBER WERE REMOVED FROM THE STORE AND OTHER THEATRES CONTACTED TO ASK THEM TO REMOVE ANY DIATHERMY PADS THEY HAD WITH THE SAME LOT NUMBER." IT WAS ALSO SPECIFIED THAT "BURN HAS HEALED WELL, NO FURTHER TREATMENT REQUIRED". NO FURTHER DETAILS HAVE BEEN DISCLOSED WHETHER THE PLACEMENT SITE WAS PREPPED, THE ORIENTATION OF THE DISPERSIVE ELECTRODE RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROCEDURE AND THE ACTIVATION CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600242 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH WR21A30 250728-2402 19005531595976

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other