UNIVERSAL PLUS 60-6010-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30653405011723), received between Dec 5, 2019 and Feb 12, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Self-Activation or Keying

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6010-003, MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE DEVICE WAS USED IN A LAPAROSCOPIC PROCEDURE ON (B)(6) 2025, AND ¿AT THE START OF THE LAPAROSCOPIC SURGERY, THE SUCTION AND CAUTERY ACTIVATED ON THEIR OWN WITHOUT ANY HUMAN INTERVENTION. THE PROCEDURE WAS IN ITS FIRST STAGE.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321630 ↗
• MalfunctionJul 21, 2025Self-Activation or Keying; Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-6010-003 MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE) DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED WAS REPORTED ¿DEPENDING ON THE ORIENTATION OF THE CORD, THE POWER WILL TURN ON AUTOMATICALLY WITHOUT PRESSING THE BUTTON.". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553577 ↗
• MalfunctionNov 19, 2024Self-Activation or Keying; Self-Activation or Keying

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6010-003, MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE DEVICE WAS USED ON (B)(6) 2024 IN AN UNNAMED PROCEDURE, AND ¿THERE WAS ALSO AN INCIDENT WHERE THE ELECTRICAL CURRENT SOUND SUDDENLY SOUNDED EVEN THOUGH THE CUT BUTTON WAS NOT PRESSED.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE "PROBABLY" WAS "INACTIVE, BUTTON WAS NEVER PRESSED, AND THE DEVICE STARTED AUTOMATICALLY ON ITS OWN (BUTTON WAS NOT STUCK). NO MENTIONED THERE WAS ANY INJURY TO A PATIENT/USER". THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. THE 60-5274-132, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING WILL BE LISTED AS A CONCOMITANT DEVICE. THERE ARE NO ALLEGATIONS FILED AGAINST IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722799 ↗
• MalfunctionAug 15, 2024Self-Activation or Keying; Self-Activation or Keying

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-6010-003, UNIVERSAL PLUS STRAIGHT-BUTTON WAS BEING USED ON (B)(6) 2024 AND ¿UNINTENDED OUTPUT OCCURRED EVEN THOUGH NO BUTTON WAS PRESSED.¿. THERE WAS NO IMPACT/INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS) WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989882 ↗
• MalfunctionAug 11, 2023Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6010-003, UNIVERSAL PLUS STRAIGHT-BUTTON, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THE DEVICE HAD UNINTENDED OUTPUTS DURING THE SURGERY. A DEFECTIVE OUTPUT BUTTON IS SUSPECTED.¿. THERE WAS NO INITIAL REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER QUESTIONING WAS SENT TO THE REPORTER TO CLARIFY IF SELF-ACTIVATION IS BEING REPORTED; HOWEVER, WE HAVE NOT RECEIVED AN ANSWER TO DATE. THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS), WILL BE LISTED AS THE CONCOMITANT DEVICE THAT WAS USED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. UPDATE: ON (B)(6) 2023, REPORTER STATES, "BOTH DEVICES BEEPED WHEN THOSE WERE NOT USED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508417 ↗
• MalfunctionJan 10, 2023Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-6010-003, UNIVERSAL PLUS STRAIGHT-BUTTON, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 14DEC22 WHEN IT WAS REPORTED, ¿IMMEDIATELY AFTER THE START OF USE, WATER LEAKED FROM THE DIAL PART OF THE ELECTRODE CONNECTION PART. THE SURGEON THOUGHT THE CONNECTION WAS LOOSE, AND IT LEAKED EVEN WHEN THE SURGEON CLOSED IT AGAIN. IN ADDITION, THERE WAS AN ENERGIZATION SOUND EVEN THOUGH THE (COAGULATION) OUTPUT BUTTON WAS NOT PRESSED.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE AND THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THERE WAS NO MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130833 ↗
• MalfunctionDec 5, 2019Self-Activation or Keying; Self-Activation or Keying

  CONMED (B)(4) REPORTED ON BEHALF OF THE FACILITY THAT THE 60-6010-003, UNIVERSAL PLUS STRAIGHT BUTTON HAND PIECE, AUTO-ACTIVATED DURING A PROCEDURE ON (B)(6) 2019. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE, HOWEVER TO DATE, NO NEW INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417983 ↗