ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCR (UDI 04953170239113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04953170239113), received between Oct 16, 2018 and Aug 7, 2026 — classified as 30 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (18 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 52 reports, 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 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 4, 2026Increase in Pressure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260977 ↗
• 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 20765887 ↗
• 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 20765693 ↗
• 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 20765677 ↗
• 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 MICROPERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20762910 ↗
• 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 20762032 ↗
• 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 MICROPERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

  Patient problems: Bowel Perforation

  MAUDE report 20762011 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "TRANSVERSE VERSUS LONGITUDINAL MUCOSAL INCISION DURING POEM FOR ESOPHAGEAL MOTILITY DISORDERS: A RANDOMIZED TRIAL". LONGITUDINAL INCISION IS THE COMMONLY USED INCISION FOR ENTRY INTO THE SUBMUCOSAL SPACE DURING PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL MOTILITY DISORDERS. TRANSVERSE INCISION IS ANOTHER ALTERNATIVE FOR ENTRY AND RETROSPECTIVE DATA SUGGEST IT HAS LESS OPERATIVE TIME AND CHANCE OF GAS-RELATED EVENTS. THIS WAS A SINGLE-CENTER, RANDOMIZED TRIAL CONDUCTED AT A (B)(6) HOSPITAL. PATIENTS UNDERGOING POEM FOR ESOPHAGEAL MOTILITY DISORDERS WERE RANDOMIZED INTO GROUP A (LONGITUDINAL INCISION) AND GROUP B (TRANSVERSE INCISION). THE PRIMARY OBJECTIVE WAS TO COMPARE THE TIME NEEDED FOR ENTRY INTO THE SUBMUCOSAL SPACE. THE SECONDARY OBJECTIVES WERE TO COMPARE THE TIME NEEDED TO CLOSE THE INCISION, NUMBER OF CLIPS REQUIRED TO CLOSE THE INCISION, AND DEVELOPMENT OF GAS-RELATED EVENTS. THE SAMPLE SIZE WAS CALCULATED AS FOR A NON-INFERIORITY DESIGN USING KELSEY METHOD. SIXTY PATIENTS WERE RANDOMIZED (30 IN EACH GROUP). ON COMPARING THE 2 TYPES OF INCISIONS, THERE WAS NO DIFFERENCE IN ENTRY TIME [3 (2, 5) VS 2 (1

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20501767 ↗
• InjuryOct 18, 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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED.

  Patient problems: Bowel Perforation

  MAUDE report 20481116 ↗
• InjuryOct 18, 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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED.

  Patient problems: Bowel Perforation

  MAUDE report 20481112 ↗
• InjuryOct 3, 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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED.

  Patient problems: Bowel Perforation

  MAUDE report 20364315 ↗
• InjuryOct 3, 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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED. THIS REPORT IS RELATED TO (B)(4).

  Patient problems: Bowel Perforation

  MAUDE report 20364238 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC RESECTION FOR ESOPHAGEAL GASTROINTESTINAL STROMAL TUMORS: A MULTI-CENTER FEASIBILITY STUDY". LITERATURE SUMMARY BACKGROUND: ESOPHAGEAL GASTROINTESTINAL STROMAL TUMORS (E-GISTS) ARE HIGHLY UNCOMMON AND HAVE NOT BEEN THOROUGHLY EXAMINED. OBJECTIVES: THE OBJECTIVE OF THIS MULTI-CENTER STUDY WAS TO ASSESS THE VIABILITY OF ENDOSCOPIC RESECTION (ER) IN THE TREATMENT OF E-GISTS AND TO EXPLORE ITS CLINICAL IMPLICATIONS. DESIGN: THIS WAS A MULTI-CENTER RETROSPECTIVE STUDY. CONSECUTIVE PATIENTS REFERRED TO THE FOUR PARTICIPATING CENTERS. METHODS: E-GISTS AMONG THE CONSECUTIVE SUBEPITHELIAL TUMORS (SETS) TREATED BY ER METHODS WERE ENROLLED FROM APRIL 2019 TO AUGUST 2022. CLINICOPATHOLOGICAL, ENDOSCOPIC, AND FOLLOW-UP DATA WERE COLLECTED AND ANALYZED. RESULTS: A TOTAL OF 23 PATIENTS WITH E-GISTS WERE INCLUDED FOR ANALYSIS, ACCOUNTING FOR 1.9% OF ALL THE ESOPHAGEAL SETS (1243 PATIENTS). THE AVERAGE SIZE OF THE TUMOR LESIONS WAS 2.3 CM (RANGE 1.0¿4.0 CM). WE OBSERVED THAT TUMORS LARGER THAN 2.0 CM WERE MORE LIKELY TO GROW DEEPER, WITH A STATISTICALLY SIGNIFICANT DIFFERENCE (P < 0.001). END BLOC RESECTION WAS ACHIEVED IN ALL 23 PATIENTS

  Patient problems: Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19805898 ↗
• MalfunctionJun 13, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THE DURING A THERAPEUTIC COLONOSCOPY PROCEDURE, AN EXCESSIVE AMOUNT OF PRESSURE WAS OBSERVED WHILE PERFORMING A CARBON DIOXIDE INJECTION WITH THE ENDOSCOPIC CO2 REGULATION UNIT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, WITH NO FURTHER EVENTS AND WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532030 ↗
• InjuryJun 13, 2024Increase in Pressure; Pumping Problem; Increase in Pressure; Pumping Problem

  IT WAS REPORTED BY THE FACILITY CO2 FLOW WAS SWITCHED TO AIR FLOW UNINTENTIONALLY OCCURRED DURING TEST PHASE AND THERE WAS NO PATIENT HARM. THIS EVENT IS FOR PROCEDURE THREE.

  Patient problems: Pneumothorax

  MAUDE report 19529188 ↗
• InjuryJun 13, 2024Increase in Pressure; Pumping Problem; Increase in Pressure; Pumping Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED PROBABLY AROUND 15-MINUTES. NO ADDITIONAL ANESTHESIA REQUIRED. THE PATIENT EXPERIENCED PNEUMOPERITONEUM, PNEUMOMEDIASTINUM, AND SUBCUTANEOUS EMPHYSEMA. THE PATIENT DID RECEIVE A CHEST X-RAY. THE PATIENT HAD TWO DAY STAY IN THE HOSPITAL AND HAS BEEN DISCHARGED HOME. THE EVENT IS FOR THE 2ND PROCEDURE. FOLLOW-UP INFORMATION RECEIVED IDENTIFIED FROM DOCTOR¿S MEETING NOTES INDICATED ONE OF THE PHYSICIANS RECALLS SIMILAR COMPLICATION THAT OCCURRED DURING POEM (PERORAL ENDOSCOPIC MYOTOMY,) AND A COMPLICATION AFTER ESD. THIS WAS ABOUT 5 YEARS AGO USING CV-190-VIDEO SYSTEM CENTER. THE INITIAL THOUGHT WAS THAT MAYBE AIR SHOULD BE OBSOLETE BUT ACKNOWLEDGED THAT IT IS STILL REQUIRED FOR SOME PROCEDURES SO NOT POSSIBLE TO ELIMINATE AS AN OPTION. CO2 WAS MADE STANDARD IN AMSTERDAM AS FAR AS 10 YEARS AGO, MAINLY FOR COMFORT OF THE PATIENT DURING COLONOSCOPIES. THIS EXTENDED TO BE USED IN OTHER PROCEDURES. CO2 WAS ALWAYS USED FOR POEM. THE PHYSICIAN NOTED THAT CO2 SHOULD BE INTEGRATED INTO THE PROCESSOR (CV-1500) TO MAKE IT FOOLPROOF. PREVIOUSLY (WHEN POEM WAS FIRST PERFORMED), IT WAS STANDARD PRACTICE TO DO X-RAY NEXT DAY AFTER THE PROCEDURE, BUT

  Patient problems: Pneumoperitoneum; Pneumothorax

  MAUDE report 19528991 ↗