ERGO D4240Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10845854013144), received between May 13, 2022 and Apr 3, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE HANDLE IS HEATING UP DURING USE AND CANNOT BE USED NORMALLY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE 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 21760651 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE WAS FOUND DURING PRE-OP TESTING ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿GETS HOT AND STOPS RUNNING.¿. 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 21686352 ↗
• MalfunctionFeb 12, 2025Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE WAS FOUND DURING PRE-OPERATIVE TESTING ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿HEAT.¿. 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 21363129 ↗
• MalfunctionJan 28, 2025Overheating of Device; Overheating of Device

  A CUSTOMER REPORTED THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿OVERHEATING, NO PATIENT IMPACT¿ OCCURRED. FURTHER ASSESSMENT FOUND THE SURGERY WAS COMPLETED AS NORMAL WITH THE USE OF AN ALTERNATE D4240. THERE WAS NO DELAY, AND NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR 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 21251126 ↗
• MalfunctionJan 16, 2025Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE WAS BEING USED ON (B)(6) 2025 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿HANDLE HEATING UP WITH USE AND CAUSING ERROR MESSAGE.¿THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SHAVER DEVICE AND 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 21171902 ↗
• MalfunctionDec 26, 2024Overheating of Device; Overheating of Device

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE DEVICE WAS USED IN A KNEE ARTHROSCOPY PROCEDURE ON (B)(6)204, AND ¿THE HANDPIECE IS CONNECTED AND DOES THE ROTATION FUNCTION, BUT THE DOCTOR DETECTS THAT THERE ARE MANY RPM, TO WHICH WE PROCEED TO LOWER THE AMOUNT FROM THE CONSOLE, BUT IT IS NOTICED THAT THESE RPMS DO NOT DECREASE, AFTER A WHILE THE HANDPIECE HEATS UP.¿. THE PROCEDURE WAS COMPLETED WITH ANOTHER D4240. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR 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 21018821 ↗
• MalfunctionDec 11, 2024Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE WAS BEING USED ON APPROXIMATELY (B)(6) 2024 DURING A SHOULDER ARTHROSCOPY AND THE DEVICE ¿GOT REALLY HOT ON THE SURGEON'S HAND AND SHUT OFF.¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. "NOBODY WAS INJURED. THE DOCTOR SAID HE FELT IT GETTING HOT IN IS HAND AND STOPPPED USING IT AND ASKED FOR ANOTHER SHAVER HANDPIECE.". THE PROCEDURE WAS COMPLETED WITH A DELAY OF A "FEW MINUTES TO GARB ANOTHER SHAVER HANDPIECE". 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 20901419 ↗
• MalfunctionOct 23, 2024Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED ON (B)(6) 24 AND WAS ¿HOT¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. 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 20516109 ↗
• MalfunctionSep 4, 2024Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE D4240 ERGO 2-BUTTON SHAVER HANDPIECE, DEVICE WAS FOUND ON AN UNKNOWN DATE DURING PRE-OPERATIVE TESTING WHEN IT WAS REPORTED ¿HEAT AND NOISY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR 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 20138427 ↗
• MalfunctionJul 31, 2024Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿GOT VERY HOT DURING THE CASE TO THE POINT THE DOCTOR SAID IT WAS BURNING HIS HAND.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT INFORMATION FOUND THAT THE USER WAS NOT BURNED, ONLY THAT THE DEVICE GOT HOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHAVER CAUSING A 2-MINUTE DELAY. THE PATIENT WAS REPORTED AS BEING ¿FINE¿. 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 19870909 ↗
• MalfunctionMar 20, 2024Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, HAD BEEN USED IN AN UNKNOWN PROCEDURE ON APPROXIMATELY 7MAR24 WHEN IT WAS REPORTED, ¿KEEPS GETTING HOT, NO PATIENT IMPACT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 18939236 ↗
• MalfunctionMar 18, 2024Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, HAD BEEN USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿GETS HOT, NO PATIENT INJURY.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 18920403 ↗
• MalfunctionFeb 16, 2024Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING TESTED DURING PRE-OP TESTING ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE PRODUCT OVERHEATS.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER AND THERE WAS NO PATIENT INVOLVEMENT. 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 18719795 ↗
• MalfunctionFeb 13, 2024Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED THAT, AFTER RECEIVING A REPORT THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE DEVICE HAD STOPPED WORKING DURING A PROCEDURE ON (B)(6) 2024, HE TESTED THIS DEVICE ON (B)(6) 2024 AND FOUND THE ¿HANDLE GOT HOT QUICKLY WITH USE¿ AND STAYED HOT EVEN AFTER HE UNPLUGGED IT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED OUTSIDE OF SURGERY. 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 18695580 ↗
• InjuryMar 31, 2023Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE, D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DURING A DISTAL CLAVICLE EXCISION DOCTOR EXPERIENCED AND OVERHEARING OF THE 4.5 VORTEX ROUTER USING D4240 ERGO SHAVER. DOCTOR SAID THE SHAVER HANDLE GOT WARM BUT WHEN HE WENT TO REMOVE THE BUR TO PUT THE SHAVER BLADE IN IT WAS HOT TO THE TOUCH AND IS CONCERNED THIS BURNED PATIENT. AM INCIDENT REPORT HAS BEEN FILED BY THE OR AND THE SHAVER HANDPIECE IS BEING ISOLATED.¿. INITIALLY THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. FURTHER ASSESSMENT QUESTIONS WERE ASKED, AND WE HAVE BEEN INFORMED THAT THE PATIENT DID RECEIVE A ¿BURN MARK¿; HOWEVER, THE DEGREE OF BURN IS NOT KNOWN. THERE HAS BEEN NOT FURTHER REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION SINCE THAT COMMUNICATION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 16654298 ↗
• MalfunctionSep 22, 2022Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED DURING A RIGHT HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, DEVICE ¿OVERHEATED DURING RIGHT HIP ARTHROSCOPY AND BURR THAT WAS IN USE MELTED AT THE BASE (WHERE BURR INSERTS INTO SHAVER HAND PIECE). PT WAS ASSESSED AND DEEMED NOT VISIBLY AFFECTED PER SURGEON, SHAVER AND BURR WAS SWAPPED OUT IMMEDIATELY AND SURGERY CONTINUED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE, UNKNOWN DEVICE WITH A 2-MINUTE DELAY. FURTHER ASSESSMENT QUESTIONING REGARDING THE BUR WAS SENT TO THE REPORTER; HOWEVER, THE QUESTIONS WERE NOT ANSWERED BY THE REPORTER. THERE WAS NO REPORT OF ANY FRAGMENTATION OF THE BUR. 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 15469257 ↗
• MalfunctionMay 13, 2022Unintended Electrical Shock; Unintended Electrical Shock

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE D4240, ERGO 2-BUTTON SHAVER HANDPIECE, WAS BEING USED DURING A ARTHROSCOPIC KNEE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿DURING KNEE ARTHRO SURGERY, ELECTRIC SHOCK HAD HAPPENED THEREFORE A CUSTOMER ASKED INVESTIGATION TO CONMED (B)(4) SERVICE TEAM. (B)(4) SERVICE TEAM FOUND THAT IT DIDN'T PASS OUR ELECTRIC TEST DUE TO MOISTURE INSIDE OF THE CABLE'S COMPONENT. A SURGERY WAS SUCCESSFUL BY USING ANOTHER SHAVER THAT THEY HAD, AND THE PATIENT IS FINE AS WELL.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER D4240 DEVICE WHICH CAUSED A 20-MINUTE DELAY. FURTHER ASSESSMENT QUESTIONING FOUND THAT BOTH THE USER AND PATIENT FELT THE ¿SHOCK¿ FROM THE DEVICE. THE DEVICE WAS USED WITH A 9274A BLADE, UNKNOWN MFG. 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 14393825 ↗