ELECTROSURGICAL UNIT UES-40 (UDI 04953170287275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04953170287275), received between Oct 6, 2017 and Aug 11, 2025 — classified as 10 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Energy Output Problem; Energy Output Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777933 ↗
• MalfunctionMay 23, 2025Device Emits Odor; Noise, Audible; Device Emits Odor; Noise, Audible

  IT WAS REPORTED THAT THE SUBJECT DEVICE MADE AN UNUSUAL NOISE AND EMITTED A BURNING SMELL. THIS ISSUE OCCURRED DURING SERVICE/MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080713 ↗
• MalfunctionApr 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854482 ↗
• MalfunctionNov 12, 2024Thermal Decomposition of Device; Audible Prompt/Feedback Problem; Thermal Decomposition of Device; Audible Prompt/Feedback Problem

  IT WAS REPORTED THE ELECTROSURGICAL UNIT SUDDENLY ALARMS WHEN SURGERY WAS BEING PERFORMED ON PATIENTS. THE EQUIPMENT WAS REPLACED AND UPON INSPECTION IT WAS FOUND THAT THE TRANSFORMER WAS BURNT OUT. THE ISSUE OCCURRED DURING A THERAPEUTIC HYSTEROSCOPIC TREATMENT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668412 ↗
• MalfunctionSep 24, 2024Sparking; Sparking

  IT WAS REPORTED THE ELECTROSURGICAL UNIT HAD A SPARK. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293238 ↗
• MalfunctionNov 27, 2023Device Emits Odor; Device Emits Odor

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ELECTROSURGICAL UNIT HAD A BURNING SMELL, HOWEVER THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED. THE CUSTOMER ALSO MENTIONED THAT AN ERROR APPEARED, HOWEVER IT WAS NOT NOTED. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE (GROIN CUTDOWN FOR VARICOSE VEIN REMOVAL). THE PROCEDURE WAS COMPLETED WITH A FUNCTIONAL DIATHERMY UNIT WITHOUT DELAY AND WITHOUT ANY PATIENT IMPACT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213501 ↗
• InjuryNov 9, 2023Output above Specifications; Output above Specifications

  THE CUSTOMER REPORTED TO OLYMPUS THAT "THERE WAS A FALSE CONTACT DURING THE SECTION THAT CAUSED A HOLE IN THE BLADDER DURING A PROCEDURE." TWO PHYSICIANS REPORTED SEPARATE INCIDENTS. FIRST PHYSICIAN REPORTED THAT WHEN THE PEDAL WAS ACTIVATED, THE PLASMA TOOK A LONG TIME TO ACTIVATE, NOT CUTTING ON THE SURFACE BUT IN DEPTH. NO PATIENT INJURY WAS REPORTED. THE SECOND PHYSICIAN REPORTED THAT THE SAME PROBLEM OCCURRED DURING THE BLADDER RESECTION PROCEDURE WHICH GENERATED A HOLE IN THE PATIENT'S BLADDER. A CHANGE OF THE CABLE WAS DONE DURING THE PROCEDURE HOWEVER, THE PROBLEM PERSISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO INFORMATION HAS BEEN RECEIVED AT THIS TIME. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PHYSICIAN (ELECTROSURGICAL UNIT) INCIDENT AND IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: FIRST PHYSICIAN INCIDENT: (B)(6) - ELECTROSURGICAL UNIT. SECOND PHYSICIAN INCIDENT: (B)(6) - FIRST CABLE. (B)(6) - SECOND CABLE.

  Patient problems: Perforation

  MAUDE report 18103481 ↗
• MalfunctionNov 9, 2023Output above Specifications; Output above Specifications

  THE CUSTOMER REPORTED TO OLYMPUS THAT "THERE WAS A FALSE CONTACT DURING THE SECTION THAT CAUSED A HOLE IN THE BLADDER DURING A PROCEDURE." TWO PHYSICIANS REPORTED SEPARATE INCIDENTS. FIRST PHYSICIAN REPORTED THAT WHEN THE PEDAL WAS ACTIVATED, THE PLASMA TOOK A LONG TIME TO ACTIVATE, NOT CUTTING ON THE SURFACE BUT IN DEPTH. NO PATIENT INJURY WAS REPORTED. THE SECOND PHYSICIAN REPORTED THAT THE SAME PROBLEM OCCURRED DURING THE BLADDER RESECTION PROCEDURE WHICH GENERATED A HOLE IN THE PATIENT'S BLADDER. A CHANGE OF THE CABLE WAS DONE DURING THE PROCEDURE HOWEVER, THE PROBLEM PERSISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO INFORMATION HAS BEEN RECEIVED AT THIS TIME. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PHYSICIAN INCIDENT AND IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: SECOND PHYSICIAN INCIDENT: (B)(6) - ELECTROSURGICAL UNIT. (B)(6)- FIRST CABLE. (B)(6)- SECOND CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102973 ↗
• MalfunctionAug 15, 2023Sparking; Sparking

  THE CUSTOMER REPORTED THAT HIS OLYMPUS ELECTROSURGICAL UNIT HAD A SCORCHED SPOT AT THE JUNCTION FOR THE SALINE CONNECTION. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548296 ↗
• MalfunctionApr 11, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED, DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE EXHIBITED ENERGY OUTPUT WITHOUT PRESSING THE FOOTSWITCH. ACCORDING TO THE REPORT, WHEN LAPAROSCOPIC CHOLECYSTECTOMY WAS PERFORMED, THE DEVICE WAS USED TO STOP BLEEDING, IT WAS FOUND THAT ENERGY WAS UNINTENTIONALLY OUTPUT WHEN THE FOOT SWITCH WAS NOT PRESSED. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16719648 ↗
• InjuryMar 15, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNKNOWN PROCEDURE, THIS ELECTROSURGICAL UNIT DID NOT TURN ON. IT PRESENTED AN ERROR MESSAGE 02. AS REPORTED, THE PROCEDURE SHOULD HAVE TAKEN FIFTEEN (15) MINUTES BUT TOOK ONE (1) HOUR AND THIRTY (30) MINUTES TO COMPLETE. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHILE THE USER TRIED TO TURN ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WHICH TOOK SOME TIME TO TURN ON. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550268 ↗
• MalfunctionDec 19, 2022Circuit Failure; Circuit Failure

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE ELECTROSURGICAL UNIT, THE DEVICE WAS BLOWING FUSES WHEN THE POWER WAS SWITCHED ON. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, AND THE DEVICE COULD NOT BE USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT/HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE DEVICE WAS FOUND TO MAKE NOISE WHEN TURNED ON, AND THERE WAS CORROSION. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005339 ↗
• MalfunctionAug 10, 2022Output above Specifications; Output above Specifications

  THE CUSTOMER REPORTED TO OLYMPUS, THE POWER VALUES WERE ABOVE THOSE RECOMMENDED ON THE ELECTROSURGICAL UNIT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198844 ↗
• MalfunctionJun 24, 2022Noise, Audible; Noise, Audible

  A USER FACILITY REPORTED TO OLYMPUS, THE ELECTROSURGICAL UNIT EXHIBITED ABNORMAL NOISE. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO AN UNKNOWN PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801011 ↗
• MalfunctionMay 26, 2022Noise, Audible; Noise, Audible

  THE CUSTOMER REPORTED THAT THERE WAS ALARM WHEN THE DEVICE WORKED, AND THERE WAS LOUDER NOISE OF THE FAN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED DELAY. THE FAULT OCCURRED AFTER USE. THE CUSTOMER FURTHER REPORTED THAT THE DEVICE DID NOT WORK WITH ALARM WHEN THE DEVICE WAS ACTIVATED. THE USER DID NOT REMEMBER THE SPECIFIC ERROR CODE, IT WAS SAID THAT THE ERROR CODE APPEARED IN THE SCREEN WHEN THE DEVICE WORKED. IT WAS INITIALLY THOUGHT THAT THE CIRCUIT BOARD WAS DEFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503346 ↗
• InjuryMay 18, 2022Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTS DURING A TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE USING AN ELECTRICAL SURGICAL UNIT WITH A FOOT PEDAL, AFTER ABOUT AN HOUR OF USE, THE PHYSICIAN RELEASED THE FOOT PEDAL, BUT THE DEVICE DID NOT DISENGAGE RESULTING IN A HOLE IN THE PATIENT¿S BLADDER. THE OPERATION WAS ABANDONED, AND THE PATIENT WAS SENT TO RECOVERY. THE SURGEON IS A REGULAR USER OF THE EQUIPMENT AND DOES NOT BELIEVE THIS WAS CAUSED BY TO USER ERROR. THE NEXT SCHEDULED MAINTENANCE FOR THE DEVICE WAS DUE (B)(6). THE DEVICE HAS WORKED FINE ON PRIOR PROCEDURES. THE CUSTOMER HAS REQUESTED A FIELD SERVICE COORDINATOR TO COME IN AND INSPECT THE EQUIPMENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ELECTROSURGICAL UNIT USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE FOOT PEDAL USED IN THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14428205 ↗
• MalfunctionAug 5, 2021Noise, Audible; Noise, Audible

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING A PROCEDURE OF FISTULA AND TRANS-URETHRAL RESECTION IN SALINE WITH SUBJECT DEVICE, ABNORMAL NOISE WAS GENERATED FROM THE SUBJECT DEVICE. THE USER COMPLETED THE PROCEDURE BY USING THE SUBJECT DEVICE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12279102 ↗
• MalfunctionJan 18, 2021Energy Output Problem; Energy Output Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION OF THE SUBJECT DEVICE FOR REPAIR AT OLYMPUS (B)(4), THE MONO POLAR OUTPUT ERROR, ALARM DUE TO CORRUPTION OF THE INTERFACE AT THE FRONT PANEL, RUST IN THE LOWER PART OF THE FRONT PANEL AND ON THE BOTTOM, AND RUSTED SCREWS OF THE HOUSING OF THE SUBJECT DEVICE WERE FOUND. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11184291 ↗
• MalfunctionNov 24, 2020Break; Break

  OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE TOP COVER OF THE DEVICE WAS SCRATCHED. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10894450 ↗
• MalfunctionNov 20, 2020Electrical /Electronic Property Problem; Failure to Power Up; Smoking; Electrical /Electronic Property Problem; Failure to Power Up; Smoking

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE END OF THE PROCEDURE, THE SUBJECT DEVICE MADE A POPPING SOUND AND SMOKE WAS GENERATED FROM THE SUBJECT DEVICE. OLYMPUS (B)(4) ((B)(4)) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE SUBJECT DEVICE COULD NOT BE TURNED ON THE POWER AND THE FRONT PANEL COULD NOT FUNCTION, ALSO THE POWER SUPPLY UNIT HAD FAILURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875902 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT A PATIENT COMPLAINED OF PAIN 5 TO 7 DAYS AFTER A TRANS-URETHRAL RESECTION OF THE PROSTATE (TURP) USING THE SUBJECT DEVICE. THE USER FACILITY DIAGNOSED THE PATIENT AND FOUND THE URETHRA RUPTURE AND THE URETHRAL BURNS. IT WAS REPORTED THAT THERE WAS NO MALFUNCTION ON THE SUBJECT DEVICE. THERE WAS NO FURTHER DETAILED INFORMATION REPORTED.

  Patient problems: Burn(s)

  MAUDE report 9822214 ↗
• InjuryNov 1, 2019Use of Device Problem; Use of Device Problem

  DURING THE PROCEDURE OF HERNIA REPAIR WITH THE UES-40, THE USER NOTICED SPARK ON THE INNER SIDE OF THE THIGH OF THE PATIENT. THE USER HAD ATTACHED THE PATIENT PLATE ON THE OUTER SIDE OF THE THIGH OF THE PATIENT. THE USER CONFIRMED THERE WAS NO CABLES OR METAL DEVICE ON THE INNER SIDE OF THE THIGH OF THE PATIENT. THE USER REPLACED THE SUBJECT UES-40 TO ANOTHER UNSPECIFIED NON-OLYMPUS GENERATOR TO COMPLETE THE PROCEDURE. THE USER REPORTED THAT THE SKIN OF INNER SIDE OF THE THIGH OF THE PATIENT BECAME RED AND THE SCROTUM OF THE PATIENT GOT MINOR BURNS. LOCAL DEPARTMENT OF OLYMPUS (B)(6) REPORTED THE FOLLOWING INSPECTION RESULT OF THE SUBJECT DEVICE. THERE WAS NO ABNORMALITY OF THE SUBJECT DEVICE. THE PHENOMENON HAS BEEN OCCURRED BY MISHANDLING.

  Patient problems: Burn(s)

  MAUDE report 9264873 ↗
• MalfunctionDec 6, 2018Failure to Deliver Energy; Failure to Deliver Energy

  DURING THE UNSPECIFIED THERAPEUTIC PROCEDURE WITH THE UES-40, THE USER FELT THE OUTPUT OF THE UES-40 WAS NOT APPROPRIATE. AFTER ACTIVATING THE UES-40 FOR UNSPECIFIED PERIODS, THE USER FELT THE OUTPUT OF THE UES-40 BECAME APPROPRIATE SUDDENLY. THE USER REPLACED THE SUBJECT UES-40 WITH AN UNSPECIFIED SIMILAR SYSTEM. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT. THE LOCAL SERVICE ENGINEER REPORTED THE FOLLOWING INSPECTION RESULT OF THE SUBJECT UES-40. NO MALFUNCTION OF THE SUBJECT UES-40 OCCURRED AND THE PHENOMENON THAT THE USER MENTIONED COULD NOT BE REPRODUCED. ALL MEASURED VALUES OF THE INSPECTION WERE WITHIN THE RANGE OF SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137017 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  A COUPLE OF DAYS AFTER THE TURIS-P PROCEDURE, THE BLEEDING WERE OBSERVED THROUGH THE DRAINAGE CATHETER FOR FIVE PATIENTS. THE PHYSICIAN PERFORMED THE IRRIGATION OF THE BLADDER. THE PATIENTS WERE PROLONGED THE HOSPITALIZATION.

  Patient problems: Blood Loss

  MAUDE report 6921508 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  A COUPLE OF DAYS AFTER THE TURIS-P PROCEDURE, THE BLEEDING WERE OBSERVED THROUGH THE DRAINAGE CATHETER FOR FIVE PATIENTS. THE PHYSICIAN PERFORMED THE IRRIGATION OF THE BLADDER. THE PATIENTS WERE PROLONGED THE HOSPITALIZATION.

  Patient problems: Blood Loss

  MAUDE report 6921483 ↗