ELECTROSURGICAL UNITRecalls & reported problems across all models

We found 2 models of ELECTROSURGICAL UNIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2017 and Aug 11, 2025 — classified as 18 injuries, 26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ELECTROSURGICAL UNIT problems

ELECTROSURGICAL UNIT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELECTROSURGICAL UNIT UES-40

  Unit, electrosurgical, endoscopic (with or without accessories)
  28 reports
• ELECTROSURGICAL UNIT UES-40

  Unit, electrosurgical, endoscopic (with or without accessories)
  16 reports

Recent ELECTROSURGICAL UNIT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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