UNIVERSAL PLUS 60-6010-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30653405011709), received between Jan 25, 2016 and Mar 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-6010-002, UNIVERSAL PLUS-HAND CTL PISTOL DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024 AND ¿THE PROBE CAME OFF FROM THE HANDLE DURING USE, SO WHEN THE SURGEON REATTACHED IT, ROTATION WAS NO LONGER POSSIBLE.¿. FURTHER ASSESSMENT INDICATED "THERE WAS NOT INJURED BOTH PATIENT AND USER"; "THERE WAS NO TREAT ANY MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION"; AND "THERE WAS NO FELL ANY FRAGMENTS OR COMPONENTS INTO THE PATIENT¿S BODY". HOWEVER, CONMED JAPAN LATER STATED, "I BELIEVE THAT IT HAS BEEN PROVEN THAT THERE IS NO DAMAGE OR FALLING OFF", AND PROVIDED A PHOTOGRAPH WHICH SUGGESTED POSSIBLE FRAGMENTATION OF THE DEVICE. 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 18894543 ↗
• MalfunctionFeb 8, 2022Self-Activation or Keying; Self-Activation or Keying

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-6010-002, UNIVERSAL PLUS-HAND CTL PISTOL WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿SUCTION WAS PERFORMED EVEN THOUGH THE SUCTION BUTTON HAD NOT BEEN PRESSED SINCE STARTING USE FOR THAT DEVICE.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT "IT OCCURRED FROM THE START OF USE OUT OF SURGICAL FIELD. THE DEVICE DID NOT USE FOR PATIENT.¿ THERE WAS NO DELAY TO THE PROCEDURE. 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 13479872 ↗
• MalfunctionAug 31, 2021Self-Activation or Keying; Self-Activation or Keying

  CONMED (B)(4) REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-6010-002, WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE AND CONFIRMED THAT THE POWER OUTPUT WAS STILL GOING WITHOUT PUSHING THE COAG BUTTON. THIS ISSUE HAS OCCURRED IN 2 CASES. (B)(4) WAS CREATED TO CAPTURE THE SECOND EVENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN ALTERNATE DEVICE. THERE WAS NO IMPACT/INJURY TO THE PATIENT OR USER. 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 12395871 ↗
• MalfunctionNov 14, 2017Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REJECTED ONE (B)(4) DEVICE FOR "DAMAGE- STERILE POUCH/BLISTER PACKAGE". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7027412 ↗
• Jan 25, 2016Device Remains Activated

  ON (B)(6) 2015, A UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT HAND CONTROL HANDLE, ELECTROSURGICAL, SUCTION/IRRIGATION WAS BEING UTILIZED IN A SURGICAL PROCEDURE. AS REPORTED, THE DEVICE FUNCTIONED NORMALLY AT THE BEGINNING OF THE PROCEDURE; HOWEVER, THEN THE COAG WAS STAYING ON CONTINUOUSLY, PRESUMABLY WITHOUT THE BUTTON BEING PUSHED. END-USER "CUT" THE CORD TO DEACTIVATE THE DEVICE. A SECOND UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT HAND CONTROL HANDLE WAS UTILIZED TO COMPLETE THE PROCEDURE WITHOUT ANY SURGICAL DELAY OR PATIENT INJURY. THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR INDICATION THAT ANY LONG TERM ADVERSE EFFECT HAD OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5388178 ↗