SUREFIT
Report
- Report Number
- 3007305485-2025-00161
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- September 7, 2025
- Report Date
- October 17, 2025
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- UDI-DI
- 10653405033837
- PMA / PMN Number
- K120322
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THIS EVALUATION IS FOR THE UNUSED, UNOPENED DEVICES THAT WERE RETURNED TOGETHER AS PART OF A STOCK DUMP. THE RETURNED DEVICES WERE NOT INVOLVED IN THE SEPARATE SURGERIES THAT ARE REPRESENTED BY 3007305485-2025-00160 (CEN-86368) AND 3007305485-2025-00161 (CEN-86884), AS THE ORIGINAL DEVICES WERE THROWN OUT. RECEIVED 9 BOXES OF UNOPENED 410-2000 SUREFITS WITH (B)(4) DEVICES IN EACH BOX, FOR A TOTAL OF (B)(4) TOTAL DEVICES. (B)(4) OF THE SUREFITS WERE FROM LOT 202506234 AND (B)(4) WERE FROM LOT 202505274. THE REPORTED EVENT OF ¿SWELLING AND PETECHIA WHERE THE DISPERSIVE ELECTRODE WAS PLACED¿ WAS EVALUATED THROUGH FUNCTIONAL TESTING OF ALL THE RETURNED DEVICES. SAMPLED 13 DEVICES FROM LOT 202505274 AND FOUND THAT ALL 13 DEVICES WORKED AS INTENDED. ALL DEVICES COULD BE SUCCESSFULLY RECOGNIZED BY THE SYSTEM 5000. ELECTRICITY WAS ALSO CONFIRMED TO BE FLOWING AND DETECTABLE THROUGH THE SUREFITS WITH A FLUKE 114 MULTIMETER, ID #(B)(4). ALL DEVICES PASSED FUNCTIONAL TESTING. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF (B)(4) DEVICES FOR THIS LOT NUMBER AND FAILURE MODE; AND NONE WERE CONFIRMED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) REPORTS, REGARDING (B)(4) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: RAPID REMOVAL OF THE PAD MAY CAUSE SKIN IRRITATION OR DAMAGE. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THE CUSTOMER REPORTED THAT THE DEVICE, 410-2000 SUREFIT, DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR WAS BEING USED ON 7SEP25 AND IT WAS DISCOVERED POST-OPERATIVELY THAT "¿THE PATIENT HAD SWELLING AND PETECHIA WHERE THE DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT¿¿. THE SUREFIT DEVICE WAS ¿¿SECURELY SECURED TO THE THIGH MUSCLE.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED AND NO PROLONGED HOSPITALIZATION FOR THE PATIENT. IT WAS ALSO REPORTED THAT THIS WAS NOT AN ALLERGIC REACTION AND THE PATIENT¿S CURRENT CONDITION IS ¿ROBUST¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PETECHIA AND SWELLING.
THE CUSTOMER REPORTED THAT THE DEVICE, 410-2000 SUREFIT, DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR WAS BEING USED ON 7SEP25 AND IT WAS DISCOVERED POST-OPERATIVELY THAT "¿THE PATIENT HAD SWELLING AND PETECHIA WHERE THE DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT¿¿. THE SUREFIT DEVICE WAS ¿¿SECURELY SECURED TO THE THIGH MUSCLE.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED AND NO PROLONGED HOSPITALIZATION FOR THE PATIENT. IT WAS ALSO REPORTED THAT THIS WAS NOT AN ALLERGIC REACTION AND THE PATIENT¿S CURRENT CONDITION IS ¿ROBUST¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PETECHIA AND SWELLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279112 | SUREFIT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | 202505274 | 10653405033837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |