ENDOSCOPIC CO2 REGULATION UNITRecalls & reported problems across all models

We found 3 models of ENDOSCOPIC CO2 REGULATION UNIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2018 and Aug 7, 2026 — classified as 40 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (22 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 ENDOSCOPIC CO2 REGULATION UNIT problems

ENDOSCOPIC CO2 REGULATION UNIT models

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

• ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR

  INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
  52 reports
• ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR

  INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
  16 reports
• ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR

  Insufflator, Automatic Carbon-Dioxide For Endoscope
  2 reports

Recent ENDOSCOPIC CO2 REGULATION UNIT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Increase in Pressure

  It was reported that after a colonoscopy procedure, the patient had a 2cm serosal tears at the cecum due to overinflation of carbon dioxide (CO2) using this CO2 regulation unit. An upright chest X-ray revealed a free intraperitoneal air, as per the physician. It was not a through and through but a damage to the wall of cecum due to overstretching. The patient was brought back to the operating room and a exploratory laparotomy, Ileocecectomy were performed. The patient was then transferred to the intensive care unit (ICU) and is currently stable. There were no further reports of patient harm.

  Patient problems: Bowel Perforation

  MAUDE report 50178275 ↗
• InjuryAug 7, 2026Increase in Pressure

  It was reported that after a colonoscopy procedure, the patient had a 2cm serosal tears at the cecum due to overinflation of carbon dioxide (CO2) using this CO2 regulation unit. An upright chest X-ray revealed a free intraperitoneal air, as per the physician. It was not a through and through but a damage to the wall of cecum due to overstretching. The patient was brought back to the operating room and a exploratory laparotomy, Ileocecectomy were performed. The patient was then transferred to the intensive care unit (ICU) and is currently stable. There were no further reports of patient harm.

  Patient problems: Bowel Perforation

  MAUDE report 50178247 ↗
• MalfunctionAug 6, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168622 ↗
• MalfunctionJun 7, 2026Increase in Pressure

  THE CUSTOMER REPORTED THAT THE UNIT WAS POSSIBLY DELIVERING OVERPRESSURE DURING SETUP INVOLVING AN OLYMPUS CARBON DIOXIDE (CO2) REGULATION UNIT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422515 ↗
• MalfunctionFeb 25, 2026Pressure Problem

  IT WAS REPORTED THAT THE CO2 REGULATION UNIT HAD DEFECTIVE REGULATION OF THE PRESSURE. IT GOES FROM LOW TO REALLY HIGH. THE ISSUE WAS FOUND DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445744 ↗
• MalfunctionFeb 24, 2026Pressure Problem

  IT WAS REPORTED THAT THE CO2 REGULATION UNIT HAD INTERMITTENT PRESSURE, HIGH PRESSURE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24432381 ↗
• MalfunctionFeb 11, 2026Infusion or Flow Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313072 ↗
• MalfunctionFeb 4, 2026Increase in Pressure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260977 ↗
• MalfunctionNov 5, 2025Increase in Pressure; Increase in Pressure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476260 ↗
• MalfunctionMay 2, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED THE FLOW OR THE QUANTITY OF GAS DELIVERED OR EXCESSIVE, THE ISSUE OCCURED DURING UNSPECIFIC PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949491 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUBJECT DEVICE HAD CAUSED A PERFORATION TO A PATIENT. THE PATIENT ALSO COMPLAINED OF ABDOMINAL PAIN. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER THERE WAS NO RESPONSE RECEIVED FROM THE CUSTOMER.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 21434899 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUBJECT DEVICE HAD CAUSED A PERFORATION TO A PATIENT. THE PATIENT ALSO COMPLAINED OF ABDOMINAL PAIN. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER THERE WAS NO RESPONSE RECEIVED FROM THE CUSTOMER.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 21434634 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NONINFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20789116 ↗
• InjuryNov 22, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICRO-PERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20765968 ↗
• InjuryNov 22, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICRO-PERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20765887 ↗

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