SKINTACT

Description of Event or Problem

ON (B)(6) 2026 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A LAPAROTOMY CONVERTED FROM VIDEOLAPAROSCOPY, DURING WHICH EXCISION OF ENDOMETRIOSIS FOCI, BILATERAL SALPINGECTOMY, LEFT OOPHORECTOMY, INTESTINAL SHAVING, AND TOTAL HYSTERECTOMY PROCEDURE WAS PERFORMED AT HOSPITAL MUNICIPAL E MATERNIDADE ESCOLA DR. MÁRIO DE MORAES ALTENFELDER SILVA IN BRAZIL. A NONE-MONITORING DISPERSIVE ELECTRODE (MODEL SKINTACT WR01) AND A WEM SS-501SX GENERATOR HAD BEEN USED. WE HAVE REQUESTED FURTHER DETAILS FOR CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE AND HAVE RECEIVED A FILLED IN QUESTIONAIRE. THE PROCEDURE LASTED FOR 3 HOURS AND 20 MINUTES. THE PATIENT WAS DESCRIBED AS OF OBESE BODY TYPE, WITH NORMAL SKIN. THE PATIENT'S SKIN WAS NOT CLEANED, NOT SHAVEN, NOT DISINFECTED, NO LOTIONS HAD BEEN USED AND NOT DRIED PRIOR APPLICATION. THE PATIENT WAS LYING IN SEMI-GYNECOLOGICAL POSITION AND WAS NOT REPOSITIONED DURING THE PROCEDURE. THE DISPERSIVE ELECTRODE WAS PLACED ON THE BACKSIDE OF THE UPPER RIGHT THIGH. THE GENERATOR SETTINGS HAVE BEEN DESCRIBED AS CUT AND COAGULATION - 35. DURING THE PROCEDURE THE SURGICAL TEAM NOTICED AN ODOR INDICATING A BURN. A PATIENT BURN WAS DISCOVERED UNDERNEATH THE GROUNDING PAD. THE USER STATED THAT "THE GROUNDING PAD WAS NOT VISIBLY DETACHED; IT SHOWED A 3.5 CM LINEAR DARKENED AREA AT THE EDGE OF THE SILVER PORTION." IT WAS ALSO STATED "AT THE TIME OF THE INCIDENT, THE LESION WAS COMPATIBLE WITH A LOCALIZED THERMAL BURN, INITIALLY MEASURING APPROXIMATELY 4.0 CM IN LENGTH BY 3.5 CM IN WIDTH, WITH AN IRREGULAR SHAPE AND ELEVATED, IRREGULAR BORDERS. IT PRESENTED A CENTRAL BLACKENED AREA SUGGESTIVE OF TISSUE NECROSIS, MEASURING 3.0 CM IN LENGTH. THROUGHOUT THE PERIPHERY OF THE DESCRIBED LESION, A 1.5 CM HALO OF DEVITALIZED TISSUE WITH A BROWNISH COLORATION WAS OBSERVED. SURROUNDING THE PERIPHERAL REGION OF THE LESION, BLISTERS WERE PRESENT THROUGHOUT ITS ENTIRE EXTENT, ASSOCIATED WITH SKIN ELEVATION. AFTER 2 (TWO) DAYS, THE LESION MEASURED 7.0 CM IN LENGTH BY 3.5 CM IN WIDTH, WITH AN IRREGULAR SHAPE AND ELEVATED, IRREGULAR BORDERS. IT PRESENTED A CENTRAL BLACKENED AREA SUGGESTIVE OF TISSUE NECROSIS, MAINTAINING THE MEASUREMENT OF 4.0 CM IN LENGTH. THROUGHOUT THE PERIPHERY OF THE DESCRIBED LESION, A 2.5 CM HALO OF DEVITALIZED TISSUE WITH A BROWNISH COLORATION WAS OBSERVED. ABSENCE OF PERIPHERAL BLISTERING LESIONS." NO INFORMATION ON THE PRECISE WOUND CARE WAS PRVIDED IT WAS STATED "THERE WAS NO MEDICAL TREATMENT; THE WOUND CARE TEAM PROVIDED CARE." WE RECEIVED ALSO FOUR PICTURES TWO SHOWING THE INVOLVED DISPERSIVE ELECTRODE FRONT [GEL] SIDE AND THE POUCH FRONT SIDE. THE FRONT GEL SIDE OF THE INVOLVED DISPERSIVE ELECTRODE IS SHOWING A BURNT AREA OPPOSITE THE CONNECTING TAB AT THE EDGE OF THE CONDUCTIVE ALUMINIUM FOIL. THE OTHER TWO PICTURES ARE SHOWING THE BURNT AREA ON THE PATIENT. WE ASSUME THE PICTURES HAVE BEEN TAKEN AT DIFFERENT DAYS. ASSUMING ONE PICTURE TAKEN IMMEDIATE AFTER THE PROCEDURE AND THE SECOND SOME DAYS LATER ON. WE ASSUME ACCORDING TO THE PICTURES THAT A 3RD DEGREE BURN MUST HAVE HAPPENED. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

Additional Manufacturer Narrative

RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON THREE RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. 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. A CONTACT QUALITY MONITORING SYSTEM MAY NOT WORK IN CONJUNCTION WITH AN UNSPLIT ELECTRODE (...)" ACCORDING TO A DATA SHEET ON THE WEM SS-501SX AVAILABLE ON THE INTERNET (HTTPS://5.IMIMG.COM/DATA5/SELLER/DOC/2022/8/QX/CX/BT/32105196/WEM-SS-501SX-MICRO-PROCESSED-ELECTROSURGICAL-UNIT.PDF), THE GENERATOR INDICATED IN THE QUESTIONNAIRE AS HAVING BEEN USED OFFERS SUCH A CONTACT QUALITY MONITORING SYSTEM (PPM® - PATIENT PLATE MONITORING). THE USE OF A NON-SPLIT ELECTRODE THEREFORE WOULD HAVE BEEN A USER-ERROR. 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.