MEGADYNE
Report
- Report Number
- 8020045-2025-00026
- Event Type
- Malfunction
- Date Received
- November 27, 2025
- Date of Event
- October 28, 2025
- Report Date
- December 11, 2025
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- UDI-DI
- 39005531507778
- PMA / PMN Number
- K063161
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. ALSO, AN ADHESION TEST WAS PERFORMED. ALL TESTED ELECTRODES WERE WITHIN LIMITS; NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. WE HAVE REQUESTED FURTHER INFORMATION, A QUESTIONNAIRE TO BE COMPLETED AND CUSTOMER SAMPLES FOR TESTING BUT HAVE RECEIVED NEITHER. THE INITIAL REPORTER HAS INFORMED US ON (B)(6) 2025: "THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS, ALSO, THE AFFECTED DEVICE WAS DISCARDED AND THEREFORE CANNOT BE ANALYZED, THIS COMPLAINT WILL BE CLOSED AS A NO PRODUCT RETURN". WE THEREFORE WILL ALSO CLOSE OUT THE INVESTIGATION AND THE REPORT. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED INCIDENT.
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. ALSO AN ADHESION TEST WAS PERFORMED. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. WE WILL PROVIDE A FOLLOW UP REPORT ONCE ANY FURTHER INFORMATION IS AVAILABLE.
ON (B)(6) 2025 WE HAVE BEEN INFORMED OF A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE MEGADYNE NEUTRAL ELECTRODES ALLOW FOR THE CAUTERY GENERATOR TO SHOW "READY" WHEN THE ELECTRODES ARE NOT ATTACHED TO THE PATIENT. THIS CAN ALLOW THE PAD TO NOT BE ATTACHED TO THE PATIENT FULLY AND THEREFORE NOT GROUNDING THE PATIENT DURING A PROCEDURE AND COULD CAUSE HARM. THERE IS NO PATIENT INJURY REPORTED. DEVICE IS AVAILABLE FOR RETURN." FURTHER ON WE HAVE BEEN INFORMED THAT "NO PATIENT CONSEQUENCE, NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT." NO FURTHER INFORMATION WAS PROVIDED ON THE GENERATOR MODEL, THE GENERATOR SETTINGS AND OTHER FURTHER DETAILS THAT MAY HAVE AN INFLUENCE ON THE INVESTIGATION.
ON NOVEMBER 04TH, 2025, WE HAVE BEEN INFORMED OF A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER: 0855C (OUR MODEL: RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE MEGADYNE NEUTRAL ELECTRODES ALLOW FOR THE CAUTERY GENERATOR TO SHOW "READY" WHEN THE ELECTRODES ARE NOT ATTACHED TO THE PATIENT. THIS CAN ALLOW THE PAD TO NOT BE ATTACHED TO THE PATIENT FULLY AND THEREFORE NOT GROUNDING THE PATIENT DURING A PROCEDURE AND COULD CAUSE HARM. THERE IS NO PATIENT INJURY REPORTED. DEVICE IS AVAILABLE FOR RETURN." FURTHER ON WE HAVE BEEN INFORMED THAT "NO PATIENT CONSEQUENCE, NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT." NO FURTHER INFORMATION WAS PROVIDED ON THE GENERATOR MODEL, THE GENERATOR SETTINGS AND OTHER FURTHER DETAILS THAT MAY HAVE AN INFLUENCE ON THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2727995 | MEGADYNE | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | RS271A30 | 250129-2403 | 39005531507778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |