SUREFIT 410-2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30653405033855), received between Dec 5, 2016 and Feb 6, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THE 410-2200, SUREFIT PAD WAS USED ON (B)(6) 2019, DURING A CAESARIAN SECTION SURGERY. THE SUREFIT 410-2200 PATIENT'S PLATE WAS ATTACHED TO THE RIGHT LEG, 1-HOUR SURGERY AFTER THE SURGERY IS FINISHED, A SKIN BURN IS FOUND ON THE LOCATION OF THE PATIENT'S PLATE. ADDITIONAL INFORMATION WAS PROVIDED AND STATED THE PATIENT RECEIVED A 1ST DEGREE BURN. SHE WAS TREATED WITH TOPICAL OINTMENT. THE PATIENT WAS NOT WEARING JEWELRY, NOR DID SHE HAVE ANY TYPE OF METAL PROSTHESIS. THE ESU UNIT DID NOT ALARM. THE BURN WAS NOTICED AFTER THE SURGERY WAS COMPLETED. PHOTOGRAPHS WERE PROVIDED OF THE SUREFIT PAD AND THE PATIENTS BURN. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8310055 ↗
• InjuryJul 20, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT, POST RADIOFREQUENCY PROCEDURE, THE PATIENT REPORTED A LESION AT THE SITE WHERE THE 410-2200 PAD WAS PLACED. THE ALLEGED LESION WAS REPORTED DAYS POST PROCEDURE AND HOSPITAL DISCHARGE. IMMEDIATELY POST PROCEDURE AND DURING RECOVERY, THE MEDICAL STAFF DID NOT FIND OR DOCUMENT ANY LESIONS ON THE PATIENT. THERE WERE NO COMPLICATIONS OR SURGICAL DELAYS DURING THE PROCEDURE. ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE, NO ADDITIONAL INFORMATION OR PHOTOGRAPHIC EVIDENCE OF THE ALLEGED LESION OR PATIENT STATUS HAS BEEN PROVIDED. THE REPORTED PAD WAS RETURNED FOR EVALUATION AND NO EVIDENCE OF ITS CONTRIBUTION TO A PATIENT INJURY WAS FOUND. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: Injury

  MAUDE report 7705887 ↗
• MalfunctionDec 5, 2016Device Stops Intermittently; Device Stops Intermittently

  AS REPORTED BY USER FACILITY, THE SUREFIT DISPERSIVE ELECTRODE, CATALOG NUMBER 410-2200, WAS NOT WORKING CONSISTENTLY DURING A COLONOSCOPY AND POLYPECTOMY. PHYSICIAN STATES "THE GROUNDING PAD SUDDENLY STOPPED WORKING. THE SNARE END CUT THROUGH THE POLYP WITH NO COAGULATION RESULTING IN SEVERE PATIENT BLEEDING. ULTIMATELY WE DID ACHIEVE HEMOSTASIS BUT WITH DIFFICULTY." FURTHER INVESTIGATION REVEALED THE BLEEDING WAS NOT LIFE-THREATENING AND THE PATIENT WAS ABLE TO BE DISCHARGED THE SAME DAY. NO ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION OF LONG TERM ADVERSE EFFECT HAS OCCURRED. IT IS UNKNOWN AT THIS TIME IF THE SUREFIT DISPERSIVE ELECTRODE WAS USED WITH THE CORRECT ELECTROSURGICAL GENERATOR EQUIPPED WITH A CONTACT MONITORING SYSTEM AND IF SUCH ALARM WAS SOUNDING TO ALERT THE SURGICAL TEAM OF POOR CONTACT OF THE GROUNDING PAD ON THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED ON MULTIPLE OCCASIONS FROM USER FACILITY, UNIVERSITY HOSPITAL OF (B)(6), BUT THERE HAS BEEN NO FURTHER INFORMATION PROVIDED TO DATE. IF CONCOMITANT DEVICES OR ANY OTHER ADDITIONAL INFO

  Patient problems: Blood Loss

  MAUDE report 6144557 ↗