MEGADYNE
Report
- Report Number
- 8020045-2016-00023
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- September 7, 2016
- Report Date
- February 28, 2017
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- PMA / PMN Number
- K063161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
AS NO LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. DESPITE OF REPEATED REQUESTS FROM US, THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFORMATION ON THE INVOLVED PRODUCT, THE PATIENT, THE NATURE OF THE PROCEDURE, HOW THE SKIN WAS PREPARED, ON THE LOCATION OF THE BURNS RELATIVE TO EACH OTHER AND THE ELECTRODE AND ON ANY TREATMENT OF THE INJURY AFTERWARDS. THE USED DEVICES ARE OFTEN USED FOR PALLIATIVE TREATMENTS OF CANCER PATIENTS. IN SUCH PROCEDURES UP TO 4 DISPERSIVE ELECTRODES ARE USED SIMULTANEOUSLY (E.G. HTTPS://WWW.BOSTONSCIENTIFIC.COM/CONTENT/DAM/BOSTONSCIENTIFIC/PI/PORTFOLIO-GROUP/RFA/RFA-FAMILY-BROCHURE-ENDO-149636-AA.PDF). THE SCOPE OF SUCH PROCEDURES IS DEFINED BY THE MANUFACTURER OF THE HF GENERATOR. HOWEVER, WE HAVE NOT YET RECEIVED ANY CONFIRMATION TO THIS EXTENT. WE WILL WAIT ANOTHER MONTH FOR MORE INFORMATION AND WILL PROVIDE YOU WITH A FURTHER FOLLOW-UP REPORT THEN. DEVICE NOT RECEIVED
AS NO LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. DESPITE OF REPEATED REQUESTS FROM US, THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFORMATION ON THE INVOLVED PRODUCT AND ON THE TREATMENT OF THE INJURY AFTERWARDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN BURN CAN BE DRAWN. WE WILL PROVIDE A FOLLOW UP REPORT WHEN WE WILL RECEIVE ADDITIONAL INFORMATION. DEVICE NOT RECEIVED.
AS NO LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. DESPITE OF REPEATED REQUESTS FROM US, THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFORMATION ON THE INVOLVED PRODUCT, THE PATIENT, THE NATURE OF THE PROCEDURE, HOW THE SKIN WAS PREPARED, ON THE LOCATION OF THE BURNS RELATIVE TO EACH OTHER AND THE ELECTRODE AND ON ANY TREATMENT OF THE INJURY AFTERWARDS. THE USED DEVICES ARE OFTEN USED FOR PALLIATIVE TREATMENTS OF CANCER PATIENTS. IN SUCH PROCEDURES UP TO 4 DISPERSIVE ELECTRODES ARE USED SIMULTANEOUSLY (E.G. HTTPS://WWW.BOSTONSCIENTIFIC.COM/CONTENT/DAM/BOSTONSCIENTIFIC/PI/PORTFOLIO-GROUP/RFA/RFA-FAMILY-BROCHURE-ENDO-149636-AA.PDF PAGE 7). THE SCOPE OF SUCH PROCEDURES IS DEFINED BY THE MANUFACTURER OF THE HF GENERATOR. HOWEVER, WE HAVE NOT YET RECEIVED ANY CONFIRMATION TO THIS EXTENT. WE HAVE REQUESTED MORE INFORMATION SEVERAL TIMES. THESE REQUESTS CONCERNED WHETHER THE PROCEDURE WAS PALLIATIVE, HOW MANY ELECTRODES WERE APPLIED TO THE PATIENT DURING THE PROCEDURE, WHETHER THE BURNS OCCURRED ONLY UNDER ONE ELECTRODE OR UNDER SEVERAL, THE LOCATION OF THE BURNS ON THE PATIENT, WHETHER DUTY CYCLES SPECIFIED IN THE IFU WERE EXCEEDED AND WHETHER THERE WAS A MISALIGNMENT OF THE ELECTRODES ACCORDING TO THE DOCUMENT: RFA FAMILY BROCHURE-ENDO-149636-AA FROM BSCI ON PAGE 7 (HTTPS://WWW.BOSTONSCIENTIFIC.COM/CONTENT/DAM/BOSTONSCIENTIFIC/PI/PORTFOLIO-GROUP/RFA/RFA-FAMILY-BROCHURE-ENDO-149636-AA.PDF/). NONE OF THIS INFORMATION HAS BEEN MADE AVAILABLE TO US DESPITE OF REPEATED REQUESTS. WE CAN THEREFORE DRAW NO FURTHER CONCLUSION AND CLOSE THE INVESTIGATION. DEVICE NOT RECEIVED.
ON SEPTEMBER 15TH, 2016, WE HAVE BEEN INFORMED THAT A PATIENT SUFFERED LIGHT BURNS AT AN UNKNOWN HOSPITAL IN (B)(6). A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RS01B30), A BOSTON SCIENTIFIC ELECTROSURGICAL GENERATOR (MODEL RF3000) AND A LEVEEN SUPERSLIM NEEDLE ELECTRODES WAS USED. THE INITIAL REPORTER STATED: "(...) WHEN THE PROCEDURE WAS FINISHED, THE PHYSICIAN REMOVED THIS DEVICES, HOWEVER THE PATIENT HAS LIGHT BURNS ON 4 PLACES OF THE THIGH. THE PERIOD OF THE PROCEDURE WAS ABOUT 1 HOUR. NO PARTICULAR PROBLEM, THEREFORE THE PATIENT WAS MOVED BACK TO THE WARD, AFTER THAT NO ANY COMPLAINTS HAVE BEEN REPORTED.(...)". NO INFORMATION ABOUT THE PATIENT, THE NATURE OF THE PROCEDURE, HOW THE SKIN WAS PREPARED AND IF AND HOW THE BURNS WERE TREATED HAVE BEEN DISCLOSED TO US DESPITE OF REPEATED REQUESTS.
ON (B)(6) 2016, WE HAVE BEEN INFORMED THAT A PATIENT SUFFERED LIGHT BURNS AT AN UNKNOWN HOSPITAL IN (B)(6). A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RS01B30), A MEGADYNE MEGA POWER ELECTROSURGICAL GENERATOR (MODEL RF3000) AND A LEVEEN SUPERSLIM NEEDLE ELECTRODES WAS USED. THE INITIAL REPORTER STATED: "(...) WHEN THE PROCEDURE WAS FINISHED, THE PHYSICIAN REMOVED THIS DEVICES, HOWEVER THE PATIENT HAS LIGHT BURNS ON 4 PLACES OF THE THIGH. THE PERIOD OF THE PROCEDURE WAS ABOUT 1 HOUR. NO PARTICULAR PROBLEM, THEREFORE THE PATIENT WAS MOVED BACK TO THE WARD, AFTER THAT NO ANY COMPLAINTS HAVE BEEN REPORTED.(...)". NO INFORMATION ABOUT THE PATIENT, THE NATURE OF THE PROCEDURE, HOW THE SKIN WAS PREPARED AND IF AND HOW THE BURNS WERE TREATED HAVE BEEN DISCLOSED TO US DESPITE OF REPEATED REQUESTS.
ON SEPTEMBER 15TH, 2016, WE HAVE BEEN INFORMED THAT A PATIENT SUFFERED LIGHT BURNS AT AN UNKNOWN HOSPITAL IN (B)(6). A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RS01B30), A BOSTON SCIENTIFIC ELECTROSURGICAL GENERATOR (MODEL RF3000) AND A LEVEEN SUPERSLIM NEEDLE ELECTRODES WAS USED. THE INITIAL REPORTER STATED: "(...) WHEN THE PROCEDURE WAS FINISHED, THE PHYSICIAN REMOVED THIS DEVICES, HOWEVER THE PATIENT HAS LIGHT BURNS ON 4 PLACES OF THE THIGH. THE PERIOD OF THE PROCEDURE WAS ABOUT 1 HOUR. NO PARTICULAR PROBLEM, THEREFORE THE PATIENT WAS MOVED BACK TO THE WARD, AFTER THAT NO ANY COMPLAINTS HAVE BEEN REPORTED.(...)". NO INFORMATION ABOUT THE PATIENT, THE NATURE OF THE PROCEDURE, HOW THE SKIN WAS PREPARED AND IF AND HOW THE BURNS WERE TREATED HAVE BEEN DISCLOSED TO US DESPITE OF REPEATED REQUESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678773 | MEGADYNE | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | RS01B30 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |