SKINTACT
Report
- Report Number
- 8020045-2026-00003
- Event Type
- Injury
- Date Received
- January 13, 2026
- Report Date
- March 2, 2026
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- PMA / PMN Number
- K063161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 501
Narratives
RETAINED SAMPLES OF THE POSSIBLE CONCERNED LOT NUMBERS 250120-4707, 250115-4706 AND 240809-4701 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES EACH POSSIBLE CONCERNED LOT NUMBER. ALL TESTED ELECTRODES WERE WITHIN LIMITS; NO FAILURE COULD BE DETECTED. ON JANUARY 13TH, 2026 THE INVOLVED DEVICE WAS RECEIVED IN AN OPEN PE POUCH. IT WAS DISINFECTED AND THEN INSPECTED. REVIEWING THE INVOLVED CUSTOMER SAMPLE IT SHOWS THREE BURNT SPOTS. THE SIZE OF ONE BURNT SPOTS IS ABOUT 4X1CM, OF ANOTHER 4X2CM AND OF ANOTHER 1X1CM. JUDGING THE BURNT SPOT WE ASSUME AT LEAST THREE 3RD DEGREE BURNS MUST HAVE HAPPENED. DUE TO THE BURN RESIDUES IN THE GEL AND THE GEL DRY-OUT CAUSED BY THE LONG STORAGE SINCE THE INCIDENT HAD HAPPENED IN (B)(6) 2025 AN ELECTRICAL TEST OR AN ADHESIVE STRENGTH TEST OF THE INVOLVED SAMPLE WAS NO LONGER POSSIBLE. WE HAVE REQUESTED FURTHER INFORMATION SEVERAL TIMES AND A FILLED IN QUESTIONNAIRE AND HAVE BEEN INFORMED THAT "I HAVEN'T RECEIVED ANY ADDITIONAL INFORMATION FROM THE USERS REGARDING THIS CASE TO THIS DAY. UNFORTUNATELY, IT WAS QUITE A LONG TIME AGO." THEREFORE, IT WAS AGREED WITH THE CUSTOMER THAT THE COMPLAINT WOULD BE CLOSED DUE TO THE LONG DURATION AND THE LACK OF FURTHER INFORMATION. AS NO FURTHER INFORMATION OR A FILLED IN QUESTIONNAIRE WAS AVAILABLE DESPITE REPEATED REQUESTS IT WAS NOT POSSIBLE TO DETERMINE IF A USER-ERROR HAS CONTRIBUTED TO OR CAUSED THE CLAIMED INCIDENT. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.
RETAINED SAMPLES OF THE POSSIBLE CONCERNED LOT NUMBERS 250120-4707, 250115-4706 AND 240809-4701 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES EACH POSSIBLE CONCERNED LOT NUMBER. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. SO FAR, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED INCIDENT. WE HAVE REQUESTED THE INVOLVED DEVICE AND ALSO THE CONCERNED LOT NUMBER AND A FILLED IN QUESTIONNAIRE FROM THE USER FACILITY. ONCE ANY FURTHER INFORMATION WILL BECOME AVAILABLE WE WILL PROVIDE A FOLLOW UP REPORT.
ON DECEMBER 17TH, 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A MONITORING DISPERSIVE ELECTRODE MODEL SKINTACT NEUTRAL ELECTRODE REF.: WR21 AND AN ERBE GENERATOR WAS USED AT INSELSPITAL BERN (UNIVERSITÄTSKLINIK) IN SWITZERLAND. THE INITIAL REPORTER INFORMED LEONHARD LANG: " THE INCIDENT APPARENTLY OCCURRED AS EARLY AS JULY 2025. UNFORTUNATELY, THE BATCH NUMBER IS UNKNOWN. THE LOTS WE SENT TO THE CUSTOMER DURING THIS PERIOD ARE 250120-4707 / 250115-4706 / 240809-4701." WE ADDITIONALLY HAVE RECEIVED A PICTURE SHOWING THE CONCERNED AND INVOLVED SKINTACT NEUTRAL ELECTRODE MODEL WR21. REVIEWING THE PICTURE IT IS CLEARLY VISIBLE A PATIENT BURN MUST HAVE HAPPENED. ON THE PICTURE THERE ARE THREE BURNT SPOTS VISIBLE AROUND THE GEL EDGE OF THE USED NEUTRAL ELECTRODE. ASSUMING THE SIZE OF THE BURNT SPOTS THERE IS A SPOT WITH ABOUT 4X1CM ANOTHER WITH 4X2CM AND ANOTHER WITH 1X1CM. WE HAVE REQUESTED FURTHER DETAILS FOR THE CONCERNED AND INVOLVED CUSTOMER SAMPLE AND A FILLED IN QUESTIONNAIRE. NO FURTHER DETAILS HAVE BEEN RECEIVED SO FAR.
ON DECEMBER 17TH, 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A MONITORING DISPERSIVE ELECTRODE MODEL SKINTACT NEUTRAL ELECTRODE REF.: WR21 AND AN ERBE GENERATOR WAS USED AT (B)(6). THE INITIAL REPORTER INFORMED (B)(6): " THE INCIDENT APPARENTLY OCCURRED AS EARLY AS JULY 2025. (...) UNFORTUNATELY, THE BATCH NUMBER IS UNKNOWN. (...) THE LOTS WE SENT TO THE CUSTOMER DURING THIS PERIOD ARE 250120-4707 / 250115-4706 / 240809-4701". WE ADDITIONALLY HAVE RECEIVED A PICTURE SHOWING THE CONCERNED AND INVOLVED SKINTACT NEUTRAL ELECTRODE MODEL WR21. REVIEWING THE PICTURE IT IS CLEARLY VISIBLE A PATIENT BURN MUST HAVE HAPPENED. ON THE PICTURE THERE ARE THREE BURNT SPOTS VISIBLE AROUND THE GEL EDGE OF THE USED NEUTRAL ELECTRODE. ASSUMING THE SIZE OF THE BURNT SPOTS THERE IS A SPOT WITH ABOUT 4X1CM ANOTHER WITH 4X2CM AND ANOTHER WITH 1X1CM. WE HAVE REQUESTED FURTHER DETAILS FOR THE CONCERNED AND INVOLVED CUSTOMER SAMPLE AND A FILLED IN QUESTIONNAIRE. NO FURTHER DETAILS HAVE BEEN RECEIVED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11260 | SKINTACT | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | WR21 | 250120-4707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |