DAHLHAUSEN
Report
- Report Number
- 8020045-2016-00025
- Event Type
- Injury
- Date Received
- November 17, 2016
- Date of Event
- September 24, 2016
- Report Date
- February 8, 2017
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- PMA / PMN Number
- K063161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND THERMALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INFORMATION PROVIDED SO FAR IS NOT SUFFICIENT TO ARRIVE AT A CONCLUSION REGARDING THE ROOT CAUSE OF THE BURN. HOWEVER, IT INDICATES THE IFU HAS NOT BEEN FOLLOWED: THE IFU SPECIFICALLY STATES "IF AN ELECTROSURGICAL UNIT OFFERS AN ELECTRODE CONTACT QUALITY MONITORING SYSTEM LIKE REM", NESSY, ARM", ETC., ALWAYS USE A SPLIT ELECTRODE." THE USER STATED IN THE QUESTIONAIRE THAT THE BITCHER (MODEL 5000) GENERATOR IS EQUIPPED WITH AN ELECTRODE CONTACT QUALITY MONITORING SYSTEM, WHICH ONLY WORKS WITH A MONITORING ELECTRODE ("SPLIT"). AN UNSPLIT NON-MONITORING ELECTRODE WAS USED. THE USE OF A SPLIT ELECTRODE COULD HAVE AVOIDED THE BURN. WE HAVE BEEN REQUESTING MORE INFORMATION ON THE PROCEDURE FROM OUR DISTRIBUTOR AND WILL FILE A FOLLOW-UP REPORT ONCE MORE INFORMATION GETS AVAILABLE. ASIDE OF THIS REPORTABLE INCIDENT OUR DISTRIBUTOR HAS INFORMED US ABOUT FOUR MORE INCIDENTS WITH THE SAME MODEL OF DISPERSIVE ELECTRODE (BUT DIFFERENT LOT NUMBERS), PRESUMABLE FROM THE SAME COUNTRY AND POSSIBLY FROM THE SAME HOSPITAL. INFORMATION ON ONE OF THESE HAS ALREADY BEEN MADE AVAILABLE TO US. WE HAVE CONCLUDED THAT THIS SECOND INCIDENT IS NOT REPORTABLE (BLISTERS, BUT NO MEDICAL INTERVENTION NECESSARY). WE HAVE REQUESTED INFORMATION ON THE REMAINING THREE ALLEGED INCIDENTS AND WILL REPORT THEM AS WILL APPEAR INDICATED ONCE THE INFORMATION BECOMES AVAILABLE. IF WE CAN IDENTIFY A TREND BASED ON THIS INFORMATION WE WILL REPORT REGARDLESS. INVOLVED DEVICE NOT RETURNED.
RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY, ELECTRICALLY AND THERMALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. ON DECEMBER 1ST, WE RECEIVED THE INVOLVED DISPERSIVE ELECTRODE SKINTACT RS05 AND SEVERAL POUCHES OF FURTHER ELECTRODES OF THE SAME LOT NUMBER AND OF A SECOND LOT NUMBER 60602-0809. THE VISUAL INVESTIGATION OF THE INVOLVED ELECTRODE SHOWED A BURNT SPOT ALONG THE EDGE OF THE GEL. THE BURNT SPOT WAS ABOUT 30MM TO 10MM. ASSESSING THE INVOLVED DEVICE WE ASSUME THAT THE INJURIES MUST HAVE BEEN THIRD DEGREE BURNS. WE CONDUCTED ELECTRICAL AND THERMAL TESTS ON THE RETURNED SAMPLES OF THE SAME LOT NUMBER INVOLVED IN THE INCIDENT AND SAMPLES OF THE SECOND LOT NUMBER 60602-0809. THE TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. THE INFORMATION PROVIDED SO FAR IS NOT SUFFICIENT TO ARRIVE AT A CONCLUSION REGARDING THE ROOT CAUSE OF THE BURN. HOWEVER, IT INDICATES THE IFU HAS NOT BEEN FOLLOWED: THE IFU SPECIFICALLY STATES "IF AN ELECTROSURGICAL UNIT OFFERS AN ELECTRODE CONTACT QUALITY MONITORING SYSTEM LIKE REM¿, NESSY®, ARM¿, ETC., ALWAYS USE A SPLIT ELECTRODE." THE USER STATED IN THE QUESTIONAIRE THAT THE BIRTCHER (MODEL 5000) GENERATOR IS EQUIPPED WITH AN ELECTRODE CONTACT QUALITY MONITORING SYSTEM, WHICH ONLY WORKS WITH A MONITORING ELECTRODE ("SPLIT"). AN UNSPLIT NON-MONITORING ELECTRODE WAS USED. THE USE OF A SPLIT ELECTRODE COULD HAVE AVOIDED THE BURN. ASIDE OF THIS REPORTABLE INCIDENT OUR DISTRIBUTOR HAS INFORMED US ABOUT FOUR MORE INCIDENTS WITH THE SAME MODEL OF DISPERSIVE ELECTRODE (BUT DIFFERENT LOT NUMBERS), PRESUMABLE FROM THE SAME COUNTRY AND POSSIBLY FROM THE SAME HOSPITAL. INFORMATION ON ONE OF THESE HAS ALREADY BEEN MADE AVAILABLE TO US. WE HAVE CONCLUDED THAT THIS SECOND INCIDENT IS NOT REPORTABLE (BLISTERS, BUT NO MEDICAL INTERVENTION NECESSARY). WE HAVE REQUESTED INFORMATION ON THE REMAINING THREE ALLEGED INCIDENTS. WE HAVE REQUESTED FURTHER INFORMATION SEVERAL TIMES AND FINALLY RECEIVED AN UPDATE FROM THE DISTRIBUTOR: "WE WILL NOT RECEIVE ANY FURTHER INFORMATION OR QUESTIONNAIRES". BASED ON THE INFORMATION MADE AVAILABLE TO US NO CONCLUSION CAN BE DRAWN. WE THEREFORE CLOSE THE INVESTIGATION.
ON (B)(6) A 2 HOUR UNKNOWN MEDICAL PROCEDURE WAS PERFORMED IN A HOSPITAL. THE NAME OF THE HOSPITAL AND THE COUNTRY HAVE NOT YET BEEN REPORTED. A NON MONITORING DISPERSIVE ELECTRODE (MODEL RS05) AND A BIRTCHER (MODEL 5000 REF: 13-2031) ELECTROSURGICAL GENERATOR WERE USED. THE ELECTRODE WAS PLACED ON THE LEFT FLANK. THE PATIENT WAS LYING IN SUPINE POSITION AND WAS NOT REPOSITIONED. THE BODY TYPE OF THE PATIENT WAS DESCRIBED AS "NORMAL (THIN)" AND THE SKIN AS NORMAL. THE SKIN WAS DRIED BUT NOT SHAVEN, NOT DISINFECTED AND NO OINTMENT HAD BEEN APPLIED. THE HOSPITAL STATED THAT THE PLATE ADHERED WELL TO THE PATIENT'S SKIN AND WAS NOT COMING OFF. AFTER THE PROCEDURE A SECOND DEGREE BURN APP. "1,5CM OF LENGTH X 0,7CM OF WIDTH" WAS DETECTED. IT WAS ALSO STATED "DRY WOUND WITH FORMATION OF DARKER TISSUE". THE BURN OCCURED UNDERNEATH THE DISPERSIVE ELECTRODE AT THE EDGE OF THE GEL AREA. "THE WOUND WAS CLEANED WITH NACL AND IT WAS MADE A DRESSING". NO INFORMATION ON THE NATURE AND LOCATION OF THE SURGICAL PROCEDURE HAVE BEEN MADE AVAILABLE SO FAR.
ON (B)(6) A 2 HOUR UNKNOWN MEDICAL PROCEDURE WAS PERFORMED IN A HOSPITAL. THE NAME OF THE HOSPITAL AND THE COUNTRY HAVE NOT YET BEEN REPORTED. A NON MONITORING DISPERSIVE ELECTRODE (MODEL RS05) AND A BIRTCHER (MODEL 5000 REF: 13-2031) ELECTROSURGICAL GENERATOR WERE USED. THE ELECTRODE WAS PLACED ON THE LEFT FLANK. THE PATIENT WAS LYING IN SUPINE POSITION AND WAS NOT REPOSITIONED. THE BODY TYPE OF THE PATIENT WAS DESCRIBED AS "NORMAL (THIN)" AND THE SKIN AS NORMAL. THE SKIN WAS DRIED BUT NOT SHAVEN, NOT DISINFECTED AND NO OINTMENT HAD BEEN APPLIED. THE HOSPITAL STATED THAT THE PLATE ADHERED WELL TO THE PATIENT'S SKIN AND WAS NOT COMING OFF. AFTER THE PROCEDURE A SECOND DEGREE BURN APP. "1,5CM OF LENGTH X 0,7CM OF WIDTH" WAS DETECTED. IT WAS ALSO STATED "DRY WOUND WITH FORMATION OF DARKER TISSUE". THE BURN OCCURED UNDERNEATH THE DISPERSIVE ELECTRODE AT THE EDGE OF THE GEL AREA. "THE WOUND WAS CLEANED WITH NACL AND IT WAS MADE A DRESSING". NO INFORMATION ON THE NATURE AND LOCATION OF THE SURGICAL PROCEDURE HAVE BEEN MADE AVAILABLE SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760402 | DAHLHAUSEN | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | RS05 | 60309-0808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |