HYFRECATOR 2000
Report
- Report Number
- 3007305485-2025-00081
- Event Type
- Malfunction
- Date Received
- May 2, 2025
- Date of Event
- April 1, 2025
- Report Date
- June 11, 2025
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K970493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
UPDATE: H10 RELATED REPORT NUMBER PROVIDED FOR REFERENCE.
EXAMINATION OF RETURNED USED DEVICE 7-900-115 FOUND THAT THE DEVICE WORKED AS INTENDED. EXAMINATION WAS DONE WITH SYSTEM 5000. NOTE THAT IF THE DEVICE IS FUNCTIONING PROPERLY, A VERY SMALL FLAME CAN BE NOTICED AT THE POINT OF CONTACT BETWEEN THE TEST SPONGE SOAKED IN SALT WATER AND THE ELECTRODE TIP. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. A DHR REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 8 COMPLAINTS, REGARDING 8 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO AVOID BURNS NEVER ALLOW CABLE ASSOCIATED WITH THIS DEVICE TO BE IN CONTACT WITH SKIN OF PATIENT OR TOUCHING OPERATOR. PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. USE LOWEST POSSIBLE POWER SETTING ON THE CONMED® HYFRECATOR® 2000 ELECTROSURGICAL GENERATOR AND SHORTEST POSSIBLE ACTIVATION TIME CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) ON (B)(6) 2025. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ DEVICE THAT WAS BEING USED DURING A SKIN TAG REMOVAL PROCEDURE ON (B)(6) 2025. THE REPORT STATED, "PT HAD SNIP REMOVAL OF SKIN TAG ON UPPER BACK. SITE WAS CLEANED, ANESTHETIZED, SKIN TAG WAS SNIPPED OFF, AND THEN CAUTERY WAS USED TO STOP BLEEDING. AFTER PRESSING CAUTERY BUTTON, THE METAL TIP DEVELOPED A FLAME. THE PATIENT WAS COMPLETELY UNHARMED AND WALKED OFF THE BED. THE CAUTERY TIP WAS THEN PLACED ON THE BED AND THEN ON TO THE GROUND. A SMALL AMOUNT OF PAPER ON THE BED THEN LIT ON FIRE, AND THIS PAPER WAS THROWN ON THE TILE AND THE FLAME STOPPED ON ITS OWN. THE PATIENT AND I WERE COMPLETELY UNHARMED, AND THE FIRE WAS PUT OUT WITHOUT ANY ASSISTANCE.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) ON 17APR2025. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ DEVICE THAT WAS BEING USED DURING A SKIN TAG REMOVAL PROCEDURE ON (B)(6) 2025. THE REPORT STATED, "PT HAD SNIP REMOVAL OF SKIN TAG ON UPPER BACK. SITE WAS CLEANED, ANESTHETIZED, SKIN TAG WAS SNIPPED OFF, AND THEN CAUTERY WAS USED TO STOP BLEEDING. AFTER PRESSING CAUTERY BUTTON, THE METAL TIP DEVELOPED A FLAME. THE PATIENT WAS COMPLETELY UNHARMED AND WALKED OFF THE BED. THE CAUTERY TIP WAS THEN PLACED ON THE BED AND THEN ON TO THE GROUND. A SMALL AMOUNT OF PAPER ON THE BED THEN LIT ON FIRE, AND THIS PAPER WAS THROWN ON THE TILE AND THE FLAME STOPPED ON ITS OWN. THE PATIENT AND I WERE COMPLETELY UNHARMED, AND THE FIRE WAS PUT OUT WITHOUT ANY ASSISTANCE.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDSUN REPORT (B)(4) ON 17APR25. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ DEVICE THAT WAS BEING USED DURING A SKIN TAG REMOVAL PROCEDURE ON (B)(6) 2025. THE REPORT STATED, ¿PT HAD SNIP REMOVAL OF SKIN TAG ON UPPER BACK. SITE WAS CLEANED, ANESTHETIZED, SKIN TAG WAS SNIPPED OFF, AND THEN CAUTERY WAS USED TO STOP BLEEDING. AFTER PRESSING CAUTERY BUTTON, THE METAL TIP DEVELOPED A FLAME. THE PATIENT WAS COMPLETELY UNHARMED AND WALKED OFF THE BED. THE CAUTERY TIP WAS THEN PLACED ON THE BED AND THEN ON TO THE GROUND. A SMALL AMOUNT OF PAPER ON THE BED THEN LIT ON FIRE, AND THIS PAPER WAS THROWN ON THE TILE AND THE FLAME STOPPED ON ITS OWN. THE PATIENT AND I WERE COMPLETELY UNHARMED, AND THE FIRE WAS PUT OUT WITHOUT ANY ASSISTANCE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192523 | HYFRECATOR 2000 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | 7-900-115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |