ENDOFLATOR UI400Recalls & reported problems
Karl Storz GmbH & Co. KG · ENDOFLATOR® 40 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Karl Storz ENDOFLATOR UI400 is an insufflator, the machine that pumps carbon dioxide gas to keep a patient's abdomen inflated during laparoscopic surgery. The 39 reports mostly describe the unit failing mid-operation: gas output dropping or pressure readings spiking, sudden shutdowns, and internal components failing, sometimes forcing surgeons to switch to open surgery. Five injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04048551326640), received between Jan 29, 2025 and Aug 13, 2026 — classified as 6 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Output Problem” (12 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem12
- Insufficient Device Problem Information9
- Defective Component8
- Gas Output Problem5
- Pressure Problem3
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event2
- Poor Quality Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Gas Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235148 ↗InjuryJul 27, 2026Output Problem
The following was reported: For the patient with appendicitis, a device system failure alert popped out after anesthesia before surgery, forcing the operation to be aborted. After physician consultation, traditional open resection was performed. The patient has been discharged normally.
Patient problems: Insufficient Information
MAUDE report 50017298 ↗MalfunctionJun 24, 2026Output Problem
THE FOLLOWING WAS REPORTED: "DURING LAPAROSCOPIC MYOMECTOMY, ONE HOUR AFTER THE START OF SURGERY, THE INSUFFLATOR AUTOMATICALLY SHUT DOWN. AFTER RESTARTING, IT DISPLAYED HIGH PRESSURE AND AUTOMATICALLY SHUT DOWN AGAIN AFTER ABOUT TEN MINUTES. THE SURGERY COULD ONLY PROCEED AFTER REPLACING WITH ANOTHER INSUFFLATOR." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25616005 ↗InjuryJun 23, 2026Output Problem
THE FOLLOWING WAS REPORTED: "ENDOFLATOR UNEXPECTEDLY STOPPED WORKING. SURGEON WAS COMPELLED TO COMPLETE THE PROCEDURE THROUGH OPEN SURGERY."
Patient problems: Insufficient Information
MAUDE report 25600466 ↗MalfunctionJun 23, 2026Output Problem
THE FOLLOWING WAS REPORTED: "ERROR 254 CONTROL STOPPED."
Patient problems: Insufficient Information
MAUDE report 25596861 ↗MalfunctionJun 15, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT CONTROL STOPPED 24C DISPLAYED DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25510493 ↗MalfunctionJun 11, 2026Increase in Pressure
IT WAS REPORTED THAT "ON (B)(6) 2026, A PNEUMOPERITONEUM MACHINE WAS USED DURING LAPAROSCOPIC SURGERY WITH THE PRESSURE SET AT 13MMHG. THE PRESSURE SUDDENLY ROSE TO 40MMHG DURING OPERATION. THE MACHINE WAS IMMEDIATELY SHUT DOWN AND REPLACED. NO HARM WAS CAUSED TO THE PATIENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479982 ↗MalfunctionJun 1, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT "3FD: POWER ON TEST ERROR" IS DISPLAYED AFTER THE DEVICE IS CONNECTING THE GAS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350313 ↗MalfunctionMay 21, 2026Output Problem
THE FOLLOWING WAS REPORTED: DURING THE LAPAROSCOPIC PROCEDURE, THE INSUFFLATOR SUDDENLY STOPPED INSUFFLATING, PREVENTING THE SURGERY FROM PROCEEDING NORMALLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246908 ↗MalfunctionMay 18, 2026Output Problem
THE FOLLOWING WAS REPORTED: "ERROR 321." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 25210885 ↗MalfunctionMay 15, 2026Defective Component; Output Problem
IT WAS REPORTED THAT "ERROR 321 SENSOR DEVIATION WAS DISPLAYED ABOUT 1 HOUR INTO THE PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25190086 ↗MalfunctionMay 6, 2026Output Problem
IT WAS REPORTED THAT ERROR 260: RESTART DEVICE WAS DISPLAYED AT THE FIRST TIME THIS DEVICE HAS BEEN USED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107415 ↗MalfunctionApr 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE UI400 INSUFFLATOR DISPLAYED SYSTEM FAILURE, SENSOR DEVIATION AND THE TC200 DISPLAYED MENU TEMPORARILY UNAVAILABLE. SPARE DEVICES WERE USED TO COMPLETE THE SURGERY AFTER 15 MINUTES DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00982.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034398 ↗MalfunctionApr 23, 2026Poor Quality Image
IT WAS REPORTED "ERROR 321: FLOW SENSOR". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971635 ↗MalfunctionApr 15, 2026Output Problem
THE FOLLOWING WAS REPORTED: DURING USE, THE INSUFFLATOR MALFUNCTIONED AND FAILED TO DELIVER GAS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889357 ↗MalfunctionApr 10, 2026Poor Quality Image
THE FOLLOWING WAS REPORTED: THERE'S ERROR 3FD. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24840640 ↗MalfunctionFeb 2, 2026Gas Output Problem
IT WAS REPORTED THAT THE UNIT HAS EXHIBITED UNSTABLE PRESSURE AND FLOW BEHAVIOR DURING OPERATION, AS DETAILED BELOW: "THE PRESET PRESSURE IS 12 MMHG. HOWEVER, ONCE THIS PRESSURE IS REACHED, THE FLOW DOES NOT RETURN TO 0 AS EXPECTED. INSTEAD, LOW-LEVEL INSUFFLATION CONTINUES (WITH FLOW FLUCTUATING BETWEEN 1-5), WHICH MAY CAUSE THE PRESSURE TO INCREASE FURTHER TO 13-15 MMHG. DURING THIS PROCESS, AN ABNORMAL VALVE OPENING AND CLOSING NOISE CAN BE HEARD". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232763 ↗MalfunctionJan 29, 2026Inflation Problem; Use of Device Problem
IT WAS REPORTED THAT "UNIT GIVES A SYSTEM FAILURE 322 ERROR". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211015 ↗MalfunctionJan 28, 2026Gas Output Problem
IT WAS REPORTED THAT THE INSUFFLATOR FROZE AND BECAME UNRESPONSIVE DURING PROCEDURE. PROCEDURE SUCCESSFULLY FINISHED WITH A BACKUP DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202961 ↗MalfunctionDec 18, 2025Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event
IT WAS REPORTED THAT DEVICE DOES NOT OPERATE WHEN TURNING ON. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839509 ↗MalfunctionDec 15, 2025Defective Component; Output Problem; Defective Component; Output Problem
IT WAS REPORTED THAT THERE WAS A SENSOR DEVIATION DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811099 ↗MalfunctionNov 26, 2025Improper Flow or Infusion; No Apparent Adverse Event; Improper Flow or Infusion; No Apparent Adverse Event
IT WAS REPORTED THAT THE FLOW COMPENSATION IS NOT WORKING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23661057 ↗MalfunctionSep 15, 2025Circuit Failure; Insufficient Device Problem Information; Circuit Failure; Insufficient Device Problem Information
IT WAS REPORTED "POWERON TEST ERROR". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058344 ↗MalfunctionSep 10, 2025Defective Component; Insufficient Device Problem Information; Defective Component; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING LAPAROSCOPIC-GYNECOLOGICAL SURGERY, THERE WAS A SUBCUTANEOUS EMPHYSEMA EXTENDING UP TO THE PATIENT'S NECK. TWO CASES OCCURRED ON THE SAME DAY IN TWO DIFFERENT PATIENTS. NO INFORMATION ABOUT ANY PRODUCT MALFUNCTION PROVIDED. NO TREATMENT OF THE SUBCUTANEOUS EMPHYSEMA WAS REQUIRED. THE PATIENTS ARE IN GOOD CONDITION; THE INCIDENT DID NOT AFFECT THEIR HEALTH. 2 COMPLAINT CASES WERE CREATED, BECAUSE OF THE 2 PATIENTS INVOLVED. (B)(4): 1. CASE, (B)(4): 2. CASE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23019517 ↗InjurySep 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING LAPAROSCOPIC-GYNECOLOGICAL SURGERY, THERE WAS A SUBCUTANEOUS EMPHYSEMA EXTENDING UP TO THE PATIENT'S NECK. TWO CASES OCCURRED ON THE SAME DAY IN TWO DIFFERENT PATIENTS. NO INFORMATION ABOUT ANY PRODUCT MALFUNCTION PROVIDED. NO TREATMENT OF THE SUBCUTANEOUS EMPHYSEMA WAS REQUIRED. THE PATIENTS ARE IN GOOD CONDITION; THE INCIDENT DID NOT AFFECT THEIR HEALTH. 2 COMPLAINT CASES WERE CREATED, BECAUSE OF THE 2 PATIENTS INVOLVED. (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23019443 ↗
Other INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE devices
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE3 recalls6 deaths2,484 reports
- ENDOFLATOR UI500Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE193 reports
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope1 recall9 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE52 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE16 reports
- CO2MPACT 710300US Endoscopy · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE4 reports
- ENDO STRATUS CO2 Insufflator EGA-501Medivators Inc. · Insufflator, Automatic Carbon-Dioxide For Endoscope2 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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