Olympus WA90004WRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04042761083560), received between Feb 7, 2020 and Dec 9, 2024 — classified as 2 deaths, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887959 ↗
• InjuryDec 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE INITIAL REPORT. NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES; HOWEVER, THERE IS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THUS, CORRECTING B1 AND B2. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. THE F10 MEDICAL DEVICE PROBLEM REPORTED WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887502 ↗
• MalfunctionMay 13, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED, THAT THE COAGULATION UNIT GAVE AN ELECTRIC SHOCK TO THE PATIENT. THE ISSUE WAS FOUND DURING THE ARGON BURN DURING COLONOSCOPY PROCEDURE WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306238 ↗
• MalfunctionDec 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN USING AN ARGON PLASMA COAGULATION UNIT ¿APU-300¿, IT STOPPED WORKING DURING A COLONOSCOPY. THE USER TRIED TO TROUBLESHOOT THE ISSUE BY REBOOTING THE SCOPE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS EVENT WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422919 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHEN USING AN ARGON PLASMA COAGULATION UNIT ¿APU-300¿, THE PATIENT EXPERIENCED A RECTAL BURN. THE DEVICE WAS TURNED ON AND THERE WERE NO FAILURE OR ERROR MESSAGES DISPLAYED AT THAT TIME. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (COLONOSCOPY WITH POLYPS REMOVAL). THE SETTINGS FOR THE ESG WERE 120 AND 4. A NON-OLYMPUS HOT SNARE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS POST-PROCEDURE DUE TO ACUTE ABDOMINAL PAIN AND RECTAL BLEEDING WITH NAUSEA AND VOMITING. CT SCAN SHOWED SOME INFLAMMATORY COLITIS WITH MURAL EDEMA SUGGESTING PROCTITIS SECONDARY TO COLONOSCOPY WITH TWO POLYPECTOMIES ¿ A LARGE POLYP IN THE RECTUM AND SMALL POLYP IN SIGMOID. A FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED REVEALING A 2 X 2.5 CM ULCER 4 CM FROM THE DENTATE LINE AND PROCTITIS. THE PATIENT SUBSEQUENTIALLY WENT INTO SEPTIC SHOCK AND WAS ADMITTED TO THE ICU ON VASOPRESSORS. THE PATIENT EVENTUALLY WAS DISCHARGED HOME AND WAS TO FOLLOW-UP WITH HIS PCP, GASTROENTEROLOGY, AND INFECTIOUS DISEASE.

  Patient problems: Abdominal Pain; Burn(s); Hemorrhage/Blood Loss/Bleeding; Nausea; Septic Shock; Vomiting

  MAUDE report 17854926 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHEN USING AN ARGON PLASMA COAGULATION UNIT ¿APU-300¿, THE PATIENT EXPERIENCED A RECTAL BURN. THE DEVICE WAS TURNED ON AND THERE WERE NO FAILURE OR ERROR MESSAGES DISPLAYED AT THAT TIME. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (COLONOSCOPY WITH POLYPS REMOVAL). THE SETTINGS FOR THE ESG WERE 120 AND 4. A NON-OLYMPUS HOT SNARE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS POST-PROCEDURE DUE TO ACUTE ABDOMINAL PAIN AND RECTAL BLEEDING WITH NAUSEA AND VOMITING. CT SCAN SHOWED SOME INFLAMMATORY COLITIS WITH MURAL EDEMA SUGGESTING PROCTITIS SECONDARY TO COLONOSCOPY WITH TWO POLYPECTOMIES ¿ A LARGE POLYP IN THE RECTUM AND SMALL POLYP IN SIGMOID. A FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED REVEALING A 2 X 2.5 CM ULCER 4 CM FROM THE DENTATE LINE AND PROCTITIS. THE PATIENT SUBSEQUENTIALLY WENT INTO SEPTIC SHOCK AND WAS ADMITTED TO THE ICU ON VASOPRESSORS. THE PATIENT EVENTUALLY WAS DISCHARGED HOME AND WAS TO FOLLOW-UP WITH HIS PCP, GASTROENTEROLOGY, AND INFECTIOUS DISEASE.

  Patient problems: Abdominal Pain; Burn(s); Hemorrhage/Blood Loss/Bleeding; Nausea; Septic Shock; Vomiting

  MAUDE report 17854370 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BURN OCCURRED WHILE USING THE ARGON PROBE. THE SEVERITY OF THE BURN WAS REPORTED AS 1ST TO 2ND DEGREE. NO MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Burn(s)

  MAUDE report 16651776 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OTHER RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Burn(s)

  MAUDE report 16651253 ↗
• DeathMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC COLONOSCOPY PROCEDURE AT AN UNKNOWN DATE, WHERE THE COLON AND THE TRANSVERSUM WERE TREATED USING SMART ARGON, THE PROCEDURE WAS FIRST BELIEVED TO HAVE BEEN FINISHED NORMALLY, WHEN THE PATIENT'S CONDITION DETERIORATED AND A FOLLOW-UP PROCEDURE WAS PLANNED. HOWEVER, THE PATIENT PASSED AWAY BEFORE IT COULD BE CARRIED OUT. THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS DURING THE INITIAL PROCEDURE.

  Patient problems: Bowel Perforation

  MAUDE report 11789035 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE THE PATIENT SUSTAINED A MINOR PERFORATION OF THE COLON WALL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bowel Perforation

  MAUDE report 10958311 ↗
• DeathFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT AFTER A PROCEDURE TO STOP THE BLEEDING OF A VASCULAR LESION IN THE DUODENUM, THE PATIENT WAS FIRST RELEASED FROM HOSPITAL BUT THEN READMITTED 24-36 HOURS LATER DUE TO A PERITONITIS. THE PATIENT WAS ADMITTED TO ICU AND A LAPAROTOMY WAS PERFORMED WHICH FOUND A DUODENAL PERFORATION. THE PATIENT ALSO ENCOUNTERED FURTHER COMPLICATIONS ON ICU, ONE BEING AN INFECTION IN THE ARM. THE PATIENT DIED 4-6 DAYS AFTER BEING READMITTED. THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS DURING THE INITIAL PROCEDURE.

  Patient problems: Bowel Perforation; Death; Peritonitis

  MAUDE report 9681367 ↗