Olympus WA90150WRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04042761085793), received between Apr 13, 2021 and Sep 9, 2026 — classified as 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701105 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem

  THE ELECTROSURGICAL GENERATOR WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF E0577. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, E0101 WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137033 ↗
• InjuryMar 4, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED DURING A THERAPEUTIC GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE IN WHICH AN ELECTROSURGICAL KNIFE WAS USED IN COMBINATION WITH AN ELECTROSURGICAL GENERATOR, A PERFORATION OCCURRED JUST BEFORE THE PROCEDURE WAS COMPLETED. THE PERFORATION OCCURRED IN THE STOMACH WITH A SIZE OF 2 OR 3 CENTIMETERS. THE LESION WAS RESECTED AND TRANSFERRED DIRECTLY TO A SURGICAL OPERATION. THE PATIENT WAS REPORTED TO BE HOSPITALIZED BUT IN GOOD HEALTH WITH NO ABNORMALITIES. THE PATIENT WAS SCHEDULED TO BE DISCHARGED. IT WAS NOTED THAT THE PHYSICIAN'S OPINION REGARDING THE DEVICE AND THE PERFORATION WAS "THE OUTPUT WITH THE NEEDLE KNIFE, WAS IT A LITTLE HIGH THAT THE EFFECT WAS 3". THERE WERE NO FURTHER REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS OBTAINED THROUGH A MEETING WITH THE PHYSICIAN. THE CUSTOMER INDICATED THERE WAS NO MALFUNCTION OR CONCERNS WITH THE ELECTROSURGICAL KNIFE AND NO TROUBLE, INCLUDING BEHAVIOR OF THE MAIN BODY, WITH THE ELECTROSURGICAL GENERATOR. IT WAS REPORTED THE PATIENT HAD ALREADY BEEN DISCHARGED FROM THE HOSPITAL THIS IS REPORT 2 OF 2.

  Patient problems: Perforation

  MAUDE report 24507844 ↗
• MalfunctionFeb 10, 2026Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305283 ↗
• MalfunctionFeb 5, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT WHEN THE POWER WAS CONNECTED AND THE SWITCH WAS PRESSED, THE OLYMPUS LOGO WAS DISPLAYED, THE GENERATOR DISPLAYED AN ERROR E0101. THE ERROR WAS NOT RESOLVED EVEN AFTER TURNING THE POWER ON AND OFF MORE THAN FIVE TIMES. THE ISSUE OCCURRED DURING INSTALLATION OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267294 ↗
• MalfunctionDec 29, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE GENERATOR HAD AN ERROR E0101 RECORDED IN THE ERROR LOG. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905002 ↗
• MalfunctionNov 24, 2025Power Problem; Power Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT GENERATOR DEVICE EXHIBITED AN ERROR CODE E0101 THAT OCCURRED IN THE HISTORY WAS RECORDED IN THE ERROR LOG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631667 ↗
• MalfunctionNov 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED AN E0101 ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627599 ↗
• InjuryNov 14, 2025Activation Failure; Activation Failure

  DURING A COLONOSCOPY, THE PHYSICIAN POSITIONED THE SNARE AROUND A POLYP AND ATTEMPTED ACTIVATION USING THE YELLOW PEDAL ON THE GENERATOR FOOTSWITCH. NO ENERGY OUTPUT WAS DELIVERED, AND THE SNARE REVERTED TO A COLD STATE. AS A RESULT, THE TISSUE WAS TRANSECTED MECHANICALLY RATHER THAN BY ELECTROCAUTERY, LEADING TO BLEEDING. THE PHYSICIAN CONTROLLED THE BLEEDING USING A CLIP, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DISCHARGED THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23555024 ↗
• InjuryNov 14, 2025Activation Failure; Activation Failure

  DURING A COLONOSCOPY, THE PHYSICIAN POSITIONED THE SNARE AROUND A POLYP AND ATTEMPTED ACTIVATION USING THE YELLOW PEDAL ON THE GENERATOR FOOTSWITCH. NO ENERGY OUTPUT WAS DELIVERED, AND THE SNARE REVERTED TO A COLD STATE. AS A RESULT, THE TISSUE WAS TRANSECTED MECHANICALLY RATHER THAN BY ELECTROCAUTERY, LEADING TO BLEEDING. THE PHYSICIAN CONTROLLED THE BLEEDING USING A CLIP, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DISCHARGED THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23555009 ↗
• MalfunctionSep 4, 2025Failure to Power Up; Failure to Power Up

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED AN E0199 ERROR DUE TO A COMPONENT FAILURE OF THE INTERNAL ELECTRONIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962257 ↗
• MalfunctionSep 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED AN E0091 ERROR MESSAGE, DUE TO A COMPONENT FAILURE OF THE INTERNAL ELECTRONIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945811 ↗
• MalfunctionAug 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED E202, E622 AND E646 ERRORS REPEATEDLY AFTER USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915984 ↗
• MalfunctionJul 14, 2025Failure to Power Up; Failure to Power Up

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL GENERATOR EXHIBITED AN E0199 ERROR DUE TO THE COMPONENT FAILURE OF THE INTERNAL ELECTRONIC BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492981 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21904505 ↗
• MalfunctionNov 12, 2024Output Problem; Output Problem

  IT WAS REPORTED THE ELECTROSURGICAL GENERATOR AN UNKNOWN ERROR MESSAGE WAS DISPLAYED WHEN OUTPUTTING. THE ISSUE OCCURRED DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667398 ↗
• InjuryJul 9, 2024Output Problem; Output Problem

  IT WAS REPORTED DURING A COLONOSCOPY POLYP REMOVAL, THE OUTPUT PRODUCED AN ERROR E0101 AFTER ACTIVATION. THE CUSTOMER LATER REPORTED THE PROCEDURE WAS CANCELLED AND RESCHEDULED; ALTHOUGH, THE PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707105 ↗
• InjuryJul 9, 2024Output Problem; Output Problem

  IT WAS REPORTED DURING A COLONOSCOPY POLYP REMOVAL, THE OUTPUT PRODUCED AN ERROR E0101 AFTER ACTIVATION. THE CUSTOMER LATER REPORTED THE PROCEDURE WAS CANCELLED AND RESCHEDULED; ALTHOUGH, THE PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707103 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SETTINGS FOR THE ESG-150 ARE IT KNIFE IS PULSE CUT SLOW EFFECT 3 40W FORCED COAG, EFFECT 3 25W HEMOSTATIC FORCEPS ARE SOFT COAG EFFECT 4 80W. IT WAS THOUGHT BY THE USER THAT THE EFFECT MAY HAVE BEEN HIGH, AND THE USER ENDED UP TALKING ABOUT LOWERING THE SETTING BY ONE BY ONE NEXT TIME.

  Patient problems: Internal Organ Perforation

  MAUDE report 18793733 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED, THAT THE ELECTROSURGICAL GENERATOR ESG-150 HAD THE FOOT PEDAL NOT MAKE CONTACT WITH THE GENERATOR. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754339 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE SUBJECT DEVICE WAS NOT INSPECTED. THE SETTING MODE AND OUTPUT VALUE ARE AS FOLLOWS: PULSE CUT FIRST EFFECT 10W AND FORCED CORE EFFECT 30W. AFTER THE POLYPECTOMY, BLEEDING DID NOT STOP, THEREFORE A CLIP AND LIGATURE WERE USED TO STOP THE BLEEDING, AND THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL FOR HOSPITALIZATION AND OBSERVATION. AFTER THAT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER CONFIRMING THAT THERE WAS NO BLEEDING.

  Patient problems: Melena

  MAUDE report 17995792 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS FURTHER RECEIVED INFORMATION THAT THE PATIENT RECEIVED IV TREATMENT AT ANOTHER HOSPITAL, AND THE MELENA STOPPED. THE SUBJECT DEVICE WAS NOT INSPECTED PRIOR TO USE. THE SETTING MODE AND OUTPUT VALUE WERE: PULSE CUT FIRST EFFECT (1) 10W, FORCED COAG EFFECT (3) 30W.

  Patient problems: Melena

  MAUDE report 17995701 ↗
• InjuryFeb 22, 2023Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING A COLONOSCOPY, THE ELEKTROCHIRURGIEGERÄT "ESG-150" STOPPED WORKING. AS A RESULT, THE PATIENT NEEDED TO BE TRANSFERRED TO THE EMERGENCY ROOM TO HAVE THE PROCEDURE COMPLETED WITH THE SAME DEVICE TYPE FROM A DIFFERENT PROCEDURE ROOM; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ERROR MESSAGES OR ALARMS. IT WAS UNCLEAR IF A DELAY OCCURRED, BUT THE COLONOSCOPY LASTED 45 MINUTES DUE TO THE ISSUE. THE PATIENT SUSTAINED A RECTAL BLEED FROM THE POLYPECTOMY SITE, POSSIBLY AS A RESULT OF THE DEVICE NOT FUNCTIONING PROPERLY. DESPITE MULTIPLE ATTEMPTS, INTERVENTIONS AND PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16418059 ↗
• InjuryFeb 22, 2023Intermittent Energy Output

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING A COLONOSCOPY, THE ELEKTROCHIRURGIEGERÄT "ESG-150" STOPPED WORKING. AS A RESULT, THE PATIENT NEEDED TO BE TRANSFERRED TO THE EMERGENCY ROOM TO HAVE THE PROCEDURE COMPLETED WITH THE SAME DEVICE TYPE FROM A DIFFERENT PROCEDURE ROOM; THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ERROR MESSAGES OR ALARMS. IT WAS UNCLEAR IF A DELAY OCCURRED, BUT THE COLONOSCOPY LASTED 45 MINUTES DUE TO THE ISSUE. THE PATIENT SUSTAINED A RECTAL BLEED FROM THE POLYPECTOMY SITE, POSSIBLY AS A RESULT OF THE DEVICE NOT FUNCTIONING PROPERLY. DESPITE MULTIPLE ATTEMPTS, INTERVENTIONS AND PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16418037 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE CUSTOMER HAD EXPERIENCED EXCESS BLEEDING OF THE PATIENT(S) DURING AT LEAST ONE UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT A MALFUNCTION OF THE MEDICAL DEVICES USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13902975 ↗