ELECTROSURGICAL UNIT UES-40 (UDI 04953170165429)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170165429), received between Jul 30, 2019 and Aug 7, 2024 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TWO-YEAR FOLLOW-UP COMPARING REZUM THERAPY VERSUS BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE FOR TREATING BENIGN PROSTATIC HYPERPLASIA. A PROSPECTIVE RANDOMIZED STUDY". LITERATURE SUMMARY: OBJECTIVE: COMPARISON OF THE EFFICACY AND SAFETY OF REALM THERAPY AND BIPOLAR TRANSURETHRAL RESECTION OF PROSTATE (B-TURP) FOR THE MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) OF 50-120 G SIZE. METHODS: ONE HUNDRED PATIENTS WITH BPH WHO MET THE INCLUSION CRITERIA WERE INCLUDED AND SPLIT INTO TWO EQUAL GROUPS TO UNDERGO REZUM THERAPY OR B-TURP. THE TWO GROUPS WERE COMPARED FOR EFFICACY USING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), QUALITY OF LIFE (Q00, MAXIMUM URINARY FLOW RATE (QMAX), OPERATIVE TIME, CATHETER TIME, HOSPITAL STAY, POST-VOID RESIDUAL URINE (PVR), PROSTATE-SPECIFIC ANTIGEN (PSA), AND RESIDUAL PROSTATE SIZE AND SAFETY USING THE INCIDENCE OF COMPLICATIONS. RESULTS: REZUM SIGNIFICANTLY AMELIORATED IPSS FROM THE BASELINE SCORE BY 55.3%, QOL BY 50%, QMAX BY 62.5%, INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF) BY 7.1%, PVR BY 50%, RESIDUAL PROSTATE SIZE BY 28.1% AND PSA BY 42% AT 2 YEARS. MEANWHILE, THE IMPROVEMENT IN B-TUR

  Patient problems: Erectile Dysfunction; Hematuria; Micturition Urgency; Unspecified Reproductive System or Breast Problem; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 19934625 ↗
• InjuryJul 5, 2024Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED, DURING THE UNSPECIFIED OPERATION USING THE ELECTROSURGICAL UNIT, THE HIGH VOLTAGE WIRES GOT TWISTED AND CAME INTO CONTACT WITH EACH OTHER WITHOUT INSULATED PARTS. THIS CAUSED AN INCREASE IN POWER AND IMPACT ON THE PATIENT, CAUSING REDNESS OF THE PATIENT'S SKIN. THE PATIENT RECEIVED A STAGE 2 BURN, 0.3% OF THE SOFT TISSUE OF THE RIGHT LOWER EXTREMITY FROM THE GROUNDING PLATES OF THE ELECTROSURGICAL COAGULATOR. THERE WAS A CABLE FAULT FROM THE DEVICE TO THE PLATE. THE CABLE FROM THE ELECTRODE BROKE RESULTING IN CONTACT WITH THE SKIN. ACCORDING TO INFORMATION RECEIVED FROM THE HOSPITAL, THE PATIENT IS RECOVERING AND HIS CONDITION IMPROVED. A STAFF ERROR OCCURRED ON THE OPERATING TABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19681604 ↗
• MalfunctionJun 11, 2024Output above Specifications; Output above Specifications

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ELECTROSURGICAL UNIT EXHIBITED POWERS OUTSIDE THE PERMITTED RANGE IN THE CUTTING AND COAGULATION TESTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511114 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AUTHOR THAT AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19370731 ↗
• MalfunctionSep 15, 2023Failure to Power Up; Failure to Power Up

  AN OLYMPUS FIELD SERVICE ENGINEER REPORTED ON BEHALF OF THE CUSTOMER THAT THE ELECTROSURGICAL UNIT¿S POWER SWITCH DID NOT TURN ON. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: ABNORMAL SOUND COMING FROM EQUIPMENT DUE TO FAULTY PRINTED CIRCUIT BOARD. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761081 ↗
• MalfunctionAug 7, 2023Environmental Particulates; Environmental Particulates

  THE CUSTOMER RETURNED HIS OLYMPUS ELECTROSURGICAL UNIT FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT DUST WAS INSIDE THE UNIT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DUST FOUND INSIDE THE UNIT DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469332 ↗
• MalfunctionJul 28, 2023Energy Output Problem; Energy Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ELECTROSURGICAL UNIT OUTPUT / INPUT CONNECTION SEEMS TO BE BURNED, HOWEVER, THE DEVICE IS STILL WORKING AS NORMAL. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE ON A THERAPEUTIC (HYSTROSCOPY) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND A 15-MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414561 ↗
• MalfunctionApr 19, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A PROCEDURE, EVERY TIME THE SURGEON PRESSED ON THE FOOT PEDAL ON THE ELECTROSURGICAL UNIT, AN ALARM SOUNDED THAT WAS HARD TO IGNORE. ON THE DISPLAY SCREEN, THE ERROR MESSAGE ER02 APPEARED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME SET OF EQUIPMENT AND NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770516 ↗
• MalfunctionSep 20, 2022Smoking; Sparking; Smoking; Sparking

  AS REPORTED FOR THIS EVENT BY THE OLYMPUS FIELD SERVICE ENGINEER, DURING PREPARATION FOR USE, THE DEVICE WAS FOUND TO HAVE SPARKED AND SMOKED. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PERSON. THE DEVICE WAS TAKEN OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454826 ↗
• MalfunctionJul 22, 2022Device Emits Odor; Device Emits Odor

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, COAGULATION BEGAN TO SMELL. THE SUBJECT DEVICE WAS DISCONNECTED, AND THEN IT STOPPED WORKING. IT WAS OBSERVED THERE WERE BURNT STAINS ON THE DEVICE COVER. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084983 ↗
• MalfunctionNov 24, 2021Noise, Audible; Noise, Audible

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING THE PREPARATION FOR USE, THERE WAS NO OUTPUT COMING THROUGH BOTH MONOPOLAR PORTS AND THERE WAS ABNORMAL SOUND THROUGH FAN. ERROR 02 WAS ALSO COMING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE EVENT DATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867041 ↗
• InjuryNov 10, 2021Energy Output Problem; Energy Output Problem

  THE CUSTOMER REPORTED DURING AN UNSPECIFIED BLADDER PROCEDURE USING A UES-40 ELECTROSURGICAL UNIT, THE PATIENT EXPERIENCED A BLADDER PERFORATION. THE SURGEON REQUESTED TO USE BIPOLAR DIATHERMY DURING THE PROCEDURE, SOMEONE ELSE SUGGESTED MONOPOLAR. THE SURGEON STARTED AT 100, THE LOWER SETTING, BUT NOT MUCH HAPPENED, THE POWER WAS INCREASED TO 150 THEN 200 EVENTUALLY, THE SURGEON WENT A LITTLE DEEPER AND PERFORATED THE BLADDER. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Internal Organ Perforation

  MAUDE report 12786484 ↗
• InjurySep 4, 2019Therapeutic or Diagnostic Output Failure

  THE USER FACILITY REPORTED THAT A PHYSICIAN COULD NOT REMOVE A POLYP DURING A PROCEDURE WHILE USING A UES-40 ELECTROSURGICAL UNIT. THE USER FACILITY USED THEIR UES-40 SURGMASTER ELECTROSURGICAL UNIT WITH UNNAMED 3RD PARTY SNARES. THE REPORTER SAID THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE POLYP AS THE SNARES ONLY MADE IT HALFWAY TO THREE QUARTERS OF THE WAY THROUGH THE POLYP. THE PHYSICIAN BELIEVED THE PROBLEM RESIDED WITH THE GENERATOR AND NOT THE SNARES. THE GENERATOR DID NOT DISPLAY AN ERROR CODE AND IT SEEMED TO HAVE ITS NORMAL AUDIBLE TONE WHILE IN USE. THE PATIENT WENT TO THE HOSPITAL TWO DAYS LATER AND HAD THE POLYP REMOVED, WITHOUT PROBLEMS. THE REPORTER ALSO SAID THAT THEY HAVE BEEN USING THE ELECTROSURGICAL UNIT SINCE THE EVENT WITHOUT ANY PROBLEMS. THE SNARES WERE DISPOSED AND NOT SENT TO THE ORIGINAL MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8963261 ↗
• InjurySep 4, 2019Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT A PHYSICIAN COULD NOT REMOVE A POLYP DURING A PROCEDURE WHILE USING A UES-40 ELECTROSURGICAL UNIT. THE USER FACILITY USED THEIR UES-40 SURGMASTER ELECTROSURGICAL UNIT WITH UNNAMED 3RD PARTY SNARES. THE REPORTER SAID THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE POLYP AS THE SNARES ONLY MADE IT HALFWAY TO THREE QUARTERS OF THE WAY THROUGH THE POLYP. THE PHYSICIAN BELIEVED THE PROBLEM RESIDED WITH THE GENERATOR AND NOT THE SNARES. THE GENERATOR DID NOT DISPLAY AN ERROR CODE AND IT SEEMED TO HAVE ITS NORMAL AUDIBLE TONE WHILE IN USE. THE PATIENT WENT TO THE HOSPITAL TWO DAYS LATER AND HAD THE POLYP REMOVED, WITHOUT PROBLEMS. THE REPORTER ALSO SAID THAT THEY HAVE BEEN USING THE ELECTROSURGICAL UNIT SINCE THE EVENT WITHOUT ANY PROBLEMS. THE SNARES WERE DISPOSED AND NOT SENT TO THE ORIGINAL MANUFACTURER FOR EVALUATION.

  Patient problems: Tissue Damage

  MAUDE report 8962417 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIOMED AT THE USER FACILITY REPORTED THAT WHEN USING THE UNIT, A PATIENT EXPERIENCED A SHOCK AT THE GROUNDING PAD. THERE WAS NO INFORMATION IF THERE WAS ANY ADDITIONAL HARM DONE TO THE PATIENT DUE TO BEING SHOCKED. ADDITIONALLY, THE BIOMED INDICATED THAT THE PATIENT PLATE WAS EXPIRED AND THAT THE UNIT WAS SET TO 10WATT OF POWER IN CUT MODE. THE STAFF ONLY BROUGHT THE REFERENCED UNIT FOR TESTING AND THE BIOMED NOTED THAT HE COULD NOT DETERMINE THE CAUSE OF THE REPORTED "PATIENT WAS SHOCKED AT THE PATIENT PLATE" AS THERE WAS NO PATIENT PLATE TO TEST WITH THE UNIT. THE UNIT WAS TESTED AND THE OUTPUTS OF THE UNIT WERE WITHIN THE REQUIRED RANGE.

  Patient problems: Electric Shock

  MAUDE report 8842403 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIOMED AT THE USER FACILITY REPORTED THAT WHEN USING THE UNIT, A PATIENT EXPERIENCED A SHOCK AT THE GROUNDING PAD. THERE WAS NO INFORMATION IF THERE WAS ANY ADDITIONAL HARM DONE TO THE PATIENT DUE TO BEING SHOCKED. ADDITIONALLY, THE BIOMED INDICATED THAT THE PATIENT PLATE WAS EXPIRED AND THAT THE UNIT WAS SET TO 10WATT OF POWER IN CUT MODE.

  Patient problems: Shock

  MAUDE report 8842241 ↗