ERBE
Report
- Report Number
- 8020045-2024-00021
- Event Type
- Injury
- Date Received
- October 23, 2024
- Date of Event
- September 18, 2024
- Report Date
- November 13, 2024
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- UDI-DI
- 040050147015487
- PMA / PMN Number
- K030362
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER THE 510K REFERENCE: K063161). RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 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 HAVE REQUESTED ADDITIONAL INFORMATION FOR SEVERAL TIMES AND OUR CUSTOMER INFORMED US THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]"DESPITE REPEATED REQUESTS, WE HAVE UNFORTUNATELY NOT RECEIVED ANY FURTHER USEFUL INFORMATION ON THIS MATTER AND THE CUSTOMER HAS INDICATED THAT NOTHING MORE WILL BE COMING. ACCORDING TO THE RECORDS, THIS IS NOT A DIATHERMIC BURN / TISSUE NECROSIS. IT IS ASSUMED THAT THE CAUSE IS: ALLERGIC REACTION AND/OR PARCHMENT SKIN AND AS A RESULT, SKIN IRRITATION HAS OCCURRED. THE PROCESS IS THEREFORE ALSO CLOSED ON OUR SITE." WE THEREFORE ASSUME THAT THE PATIENT CONDITION HAS CAUSED OR AT LEAST CONTRIBUTED TO THE EVENT. WE ALSO CLOSE THE INVESTIGATION AND THE REPORT.
WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER THE 510K REFERENCE: (B)(4)). RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. NO FAULTS WERE DETECTED. WE HAVE REQUESTED FOR FURTHER INFORMATION AND THE INVOLVED DEVICE BUT IT HAS NOT YET BEEN MADE AVAILABLE TO THE DATE OF THIS REPORT. CURRENTLY NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. WE WILL FURTHER INVESTIGATE AND RELAY ANY CONCLUSION IN A FOLLOW UP REPORT.
ON (B)(6)2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT VIECURI MEDISCH CENTRUM, VENLO, NETHERLANDS. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL21) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "ACCORDING TO THE USER REPORT, THE NEUTRAL ELECTRODE COULD HARDLY/VERY HARD TO BE REMOVED FROM THE SKIN.THE SKIN IS RED AND PARTIALLY DAMAGED." LATER ON, WE RECEIVED A PARTIALLY FILLED IN QUESTIONAIRE SPECIFYING THAT THE PATIENT SKIN TYPE WAS "LIKE A PARCHMENT SKIN. "PREASSUMABLY AN ERBE GENERATOR" HAD BEEN USED. "WHEN APPLYING THE ELECTRODE, IT WAS PRESSED FIRMLY ONTO THE SKIN TO ENSURE GOOD CONTACT". IT WAS STATED THAT THE INJURY WAS DETECTED AFTER THE PROCEDURE WHEN "REMOVING THE DISPERSIVE ELECTERODE". THE SKIN INJURY WAS DESCRIBED AS "SKIN IS RED AND DAMAGED. PATIENT HAS SLIGHTLY DAMAGED SKIN." THE INJURY WAS LOCATED "PROBABLY UNDER THE ADHESIVE SURFACE AND ALSO THE GEL AREA." THE PATIENT INJURY WAS TREATED BY "PROBABLY OINTMENT, BANDAGE OR SIMILAR". NO FURTHER DETAILS HAVE BEEN DISCLOSED.
ON (B)(6) 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT VIECURI MEDISCH CENTRUM, VENLO, NETHERLANDS. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL21) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "ACCORDING TO THE USER REPORT, THE NEUTRAL ELECTRODE COULD HARDLY/VERY HARD TO BE REMOVED FROM THE SKIN. THE SKIN IS RED AND PARTIALLY DAMAGED." LATER ON WE RECEIVED A PARTIALLY FILLED IN QUESTIONAIRE SPECIFYING THAT THE PATIENT SKIN TYPE WAS "LIKE A PARCHMENT SKIN. "PRESUMABLY AN ERBE GENERATOR" HAD BEEN USED. "WHEN APPLYING THE ELECTRODE, IT WAS PRESSED FIRMLY ONTO THE SKIN TO ENSURE GOOD CONTACT". IT WAS STATED THAT THE INJURY WAS DETECTED AFTER THE PROCEDURE WHEN "REMOVING THE DISPERSIVE ELECTRODE". THE SKIN INJURY WAS DESCRIBED AS "SKIN IS RED AND DAMAGED. PATIENT HAS SLIGHTLY DAMAGED SKIN." THE INJURY WAS LOCATED "PROBABLY UNDER THE ADHESIVE SURFACE AND ALSO THE GEL AREA." THE PATIENT INJURY WAS TREATED BY "PROBABLY OINTMENT, BANDAGE OR SIMILAR". NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365783 | ERBE | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | XL21 | 240226-0804 | 040050147015487 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |