BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 16500817 · Received March 8, 2023

    Report

    Report Number
    8020045-2023-00006
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 21, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    19005531593340
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. NO CUSTOMER SAMPLES ARE AVAILABLE FOR AN INVESTIGATION. WE HAVE BEEN INFORMED THAT "DUE TO A MISUNDERSTANDING WITHIN THE HOSPITAL THE REMAINING SAMPLES OF RS05 LOT 220405-0822 HAVE BEEN DISPOSED BY HOSPITAL AND THEREFORE [ARE] NO LONGER AVAILABLE TO SEND TO YOU". IT IS UNCLEAR WHETHER THE ACTIVATION CYCLES SPECIFIED IN THE IFU HAVE BEEN FOLLOWED. THE IFU STATES "PRODUCT LIMITATIONS: · EXCEEDING THE FOLLOWING LIMITATIONS MAY OVERLOAD THE NEUTRAL ELECTRODE WITH CURRENT. THIS MAY RESULT IN A PATIENT BURN DESPITE A FULLY AND CORRECTLY APPLIED NEUTRAL ELECTRODE AND AN ACTIVATED CONTACT QUALITY MONITORING SYSTEM. (...). RESTRICT THE DURATION OF ACTIVATION TO A MAXIMUM OF 60 SECONDS WITHIN EACH 2 MINUTE PERIOD. DURING CONVENTIONAL PROCEDURES ON PATIENTS WEIGHING MORE THAN 15 KG [ACCORDING TO IEC 60601-2-2:2017] ONLY SPLIT NEUTRAL ELECTRODES MUST BE USED." THE IFU ALSO STATES THE "WARNING: IMPROPER USE OF NEUTRAL ELECTRODES CAN CAUSE DAMAGE TO TISSUE. THESE INSTRUCTIONS FOR USE SERVE TO ENSURE PATIENT SAFETY. NOT FOLLOWING THESE INSTRUCTIONS MAY LEAD TO BURNS, PRESSURE NECROSES, OR OTHER SKIN TRAUMA DURING USE. (...) - IF AN ELECTROSURGICAL UNIT OFFERS A NEUTRAL ELECTRODE CONTACT QUALITY MONITORING SYSTEM ALWAYS USE A SPLIT ELECTRODE. (...) - IF THE ELECTROSURGICAL DEVICE IS EQUIPPED WITH A SYSTEM FOR MONITORING NEUTRAL ELECTRODE CONTACT QUALITY (SUCH AS REM¿, NESSY ®, ARM¿, ETC.), ALWAYS USE A SPLIT ELECTRODE." THE GENERATOR USED, AN ERBE VIO 100C, OFFERS SUCH A CONTACT QUALITY MONITORING SYSTEM (NESSY ®). WE THEREFORE CONCLUDE THAT A USER ERROR CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER CONCLUSION CAN BE DRAWN, WE THEREFORE CLOSE THE INVESTIGATION AND THE REPORT.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. WE ARE AWAITING CUSTOMER SAMPLES FROM THE CONCERNED LOT NUMBER AND A FILLED IN QUESTIONAIRE. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENT.

    Description of Event or Problem · 0

    ON FEBRUARY 09TH, 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT (B)(6) HOSPITAL (B)(6) ITALY. ON MARCH 2ND, 2023 WE HAVE RECEIVED ADDITIONAL INFORMATION ON THE PROCEDURE THE PATIENT AND A PICTURE SHOWING THE PATIENT INJURY. A REMOVAL OF SKIN LESION UNDER LOCAL ANESTHESIA PROCEDURE WAS PERFORMED. THE DURATION LASTED FOR 15 MINUTES. THE PATIENT WAS NOT REPOSITIONED. A NON-MONITORING DISPERSIVE ELECTRODE [UNSPLIT ELECTROSURGICAL NEUTRAL ELECTRODE] SKINTACT MODEL RS05 AND AN ERBE VIO100C GENERATOR WERE USED. THE PATIENT BODY TYPE WAS DESCRIBED AS SLIM AND THE SKIN WAS DESCRIBED AS "DRY, INTACT AND HAIRLESS SKIN. THE GENERATOR SETTING HAS BEEN DESCRIBED AS "DRY CUT 20, SOFT COAG 15" AND WAS NOT RAISED DURING THE PROCEDURE. THE DISPERSIVE ELECTRODE WAS PLACED ON THE LEFT SIDE OF TORSO AND THE DISTANCE TO THE SURGICAL AREA WAS ABOUT 50CM. THE DISPERSIVE ELECTRODE WAS "FULLY ADHERENT" TO THE PATIENT SKIN. THE INITIAL REPORTER STATED THAT: "AFTER POSITIONING THE NEUTRAL ELECTRODE IN AN ADEQUATE WAY, THE PATIENT FEELS A SHOCK WHEN USING THE ERBE ELECTRO-SCALPEL. THE PROCEDURE IS IMMEDIATELY SUSPENDED, THE NEUTRAL ELECTRODE IS REMOVED AND BURN AT THE LIMBAR LEVEL IS SHOWN. THEY ALSO REPORT THAT THERE IS NO MALFUNCTION OF THE ERBE ELECTROSURGICAL UNIT." THE PICTURE RECEIVED SHOWS THE PATIENT INJURY, AN ELONGATED BURN ON THE LEFT SIDE ABOUT HALFWAY BETWEEN THE HIP AND THE LEFT ARM. JUDGING BY THE PICTURE, A 3RD DEGREE BURN. THE SKIN AROUND THE BURN IS REDDISH. IT IS NOT POSSIBLE TO TELL THE SIZE BASED ON THE PICTURE. THE PATIENT INJURY WAS TREATED WITH "DRESSING WITH ANTIBIOTIC AND STEROID OINTMENT. NO FOLLOW-UP NEEDED". LATER ON WE HAVE ALSO BEEN INFORMED THAT "THE CUSTOMER ALSO ADDED THAT THEY HAVE ALREADY SEEN THE PATIENT TWO WEEKS AFTER THE ACCIDENT [...]: THE WOUND IS COMPLETELY HEALED. HE SAID THEY'VE BEEN SWAPPING UNSPLIT PLATES FOR SPLIT PLATES THROUGHOUT THE DEPARTMENT." NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON FEBRUARY 9TH, 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT HOSPITAL POLICLINICO DI MILANO, ITALY. A NON-MONITORING DISPERSIVE ELECTRODE [UNSPLIT ELECTROSURGICAL NEUTRAL ELECTRODE] SKINTACT MODEL RS05 AND AN ERBE VIO100C GENERATOR WERE USED. THE INITIAL REPORT STATED THAT: "AFTER POSITIONING THE NEUTRAL ELECTRODE IN AN ADEQUATE WAY, THE PATIENT FEELS A SHOCK WHEN USING THE ERBE ELECTRO-SCALPEL. THE PROCEDURE IS IMMEDIATELY SUSPENDED, THE NEUTRAL ELECTRODE IS REMOVED AND BURN AT THE LIMBAR LEVEL IS SHOWN. THEY ALSO REPORT THAT THERE IS NO MALFUNCTION OF THE ERBE ELECTROSURGICAL UNIT. THE PATIENT INVOLVED IS 17 YEARS OLD." ON MARCH 2ND, 2023 WE HAVE RECEIVED ADDITIONAL INFORMATION ON THE PROCEDURE THE PATIENT AND A PICTURE SHOWING THE PATIENT INJURY. A REMOVAL OF SKIN LESION UNDER LOCAL ANESTHESIA PROCEDURE WAS PERFORMED. THE PATIENT SKIN WAS DESCRIBED AS "DRY, INTACT AND HAIRLESS SKIN. THE GENERATOR SETTING HAS BEEN DESCRIBED AS "DRY CUT 20, SOFT COAG 15". THE DISPERSIVE ELECTRODE WAS PLACED ON THE LEFT SIDE OF TORSO AND THE DISTANCE TO THE SURGICAL AREA WAS ABOUT 50CM. THE DISPERSIVE ELECTRODE WAS "FULLY ADHERENT" TO THE PATIENT SKIN. THE PATIENT INJURY WAS TREATED WITH "DRESSING WITH ANTIBIOTIC AND STEROID OINTMENT. NO FOLLOW-UP NEEDED". THE RECEIVED PICTURE SHOWS THE PATIENT INJURY, AN ELONGATED BURN ON THE LEFT SIDE ABOUT HALFWAY BETWEEN THE HIP AND THE LEFT ARM. JUDGING BY THE PICTURE, A 3RD DEGREE BURN. THE SKIN AROUND THE BURN IS REDDISH. IT IS NOT POSSIBLE TO TELL THE SIZE BASED ON THE PICTURE. LATER ON WE HAVE ALSO BEEN INFORMED THAT "THE CUSTOMER ALSO ADDED THAT THEY HAVE ALREADY SEEN THE PATIENT TWO WEEKS AFTER THE ACCIDENT [...]: THE WOUND IS COMPLETELY HEALED. HE SAID THEY'VE BEEN SWAPPING UNSPLIT PLATES FOR SPLIT PLATES THROUGHOUT THE DEPARTMENT." NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164027 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS05 220405-0822 19005531593340

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other