ENDOFLATOR UI500Recalls & reported problems
Karl Storz GmbH & Co. KG · ENDOFLATOR® 50 · Class 2
Quick summary
This Karl Storz Endoflator insufflator, which delivers carbon dioxide during endoscopic procedures, has 193 reports, 25 injuries and no deaths. Many reports describe the unit shutting down, showing error messages, or failing to hold the set pressure, and a few describe too much gas being delivered during surgery. 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
- 193
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 04048551326657), received between Jan 12, 2021 and Sep 30, 2026 — classified as 25 injuries, 168 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (47 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
- Insufficient Device Problem Information47
- No Apparent Adverse Event32
- Defective Component25
- Gas Output Problem22
- Output Problem16
- Electrical /Electronic Property Problem14
- Pressure Problem14
- Pumping Stopped14
Patient problems
- No Clinical Signs, Symptoms or Conditions155
- Insufficient Information40
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bowel Burn1
- Electric Shock1
- Intra-Abdominal Hemorrhage1
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954097 ↗MalfunctionSep 22, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859950 ↗MalfunctionSep 14, 2026Energy Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765021 ↗MalfunctionSep 8, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675845 ↗MalfunctionSep 4, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616693 ↗MalfunctionAug 11, 2026Failure to Deliver Energy
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212551 ↗MalfunctionJul 27, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017637 ↗MalfunctionJun 24, 2026Display or Visual Feedback Problem
THE FOLLOWING WAS REPORTED: DEVICE DISPLAYS VALVE ERROR/ SHUTSDOWN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25613786 ↗MalfunctionJun 10, 2026Failure to Pump
IT WAS REPORTED THAT THE DEVICE IS SHOWING ERROR MESSAGE FORCING CUSTOMER TO RESTART. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25466159 ↗MalfunctionJun 6, 2026Gas Output Problem
THE FOLLOWING WAS REPORTED: MALFUNCTION DURING PROCEDURE. IT FLASHED A SYSTEM FAILURE ALERT AND PURGED THE INSUFFLATION IN THE MIDDLE OF A PROCEDURE. WE SHUT DOWN THE UNIT, EVEN CONNECTED TO A NEW CO2 TANK JUST IN CASE THERE WAS AN ISSUE THERE. IT RESTARTED AND SEEMED OK, BUT WITHIN A FEW MINUTES THE SAME THING HAPPENED. CONVERTED TO OPEN SURGERY AND THE PATIENT IS OK. SURGERY WAS A VET SURGERY. NO NEGATIVE IMPACT ON THE STATE OF HEALTH FOR A HUMAN IS REPORTED. SINCE THE DEVICE WAS USED IN A VETERINARY PROCEDURE WE DECIDED TO VOLUNTARILY REPORT THIS AS A MALFUNCTION AT LEAST TO THE US FDA, HOWEVER WE DO NOT REPORT IT AS A SERIOUS INJURY, SINCE NO HUMAN WAS AFFECTED AND THE MEDWATCH REPORTING SYSTEM IS ORIGINALLY DESIGNATED FOR HUMAN HEALTH IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418337 ↗InjuryJun 5, 2026Pressure Problem
IT WAS REPORTED THAT THE INSUFFLATOR CONSISTENTLY DISPLAYED A PRESSURE OF 13-15 MMHG; IT WAS OBSERVED THAT 80 LITERS OF CO2 WERE INSUFFLATED. INTRAOPERATIVELY, THE PATIENT DEVELOPED A THORACIC EMPHYSEMA; DESPITE A MINUTE VENTILATION OF 12 L, THE PCO2 REMAINED AROUND 50 MMHG. THIS RESULTED IN A PROLONGED EMERGENCE FROM ANESTHESIA AND THE LOOMING PROSPECT OF TRANSFER TO THE INTENSIVE CARE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418171 ↗InjuryJun 5, 2026Pressure Problem
IT WAS REPORTED THAT THE INSUFFLATOR CONSISTENTLY DISPLAYED A PRESSURE OF 13-15 MMHG; IT WAS OBSERVED THAT 80 LITERS OF CO2 WERE INSUFFLATED. INTRAOPERATIVELY, THE PATIENT DEVELOPED A THORACIC EMPHYSEMA; DESPITE A MINUTE VENTILATION OF 12 L, THE PCO2 REMAINED AROUND 50 MMHG. THIS RESULTED IN A PROLONGED EMERGENCE FROM ANESTHESIA AND THE LOOMING PROSPECT OF TRANSFER TO THE INTENSIVE CARE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417995 ↗MalfunctionJun 3, 2026Activation Problem
IT WAS REPORTED THAT AFTER THE UNIT RETURNED FROM REPAIR IT IS NOW DEFECTIVE AND SHOWING AN ERROR MESSAGE WHEN CONNECTED: SYSTEM FAILURE OCCURRED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382368 ↗MalfunctionJun 1, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT "ERROR 382".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350677 ↗MalfunctionMay 21, 2026Pressure Problem
IT WAS REPORTED THAT THE GAS PRESSURE IS TOO LOW. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247912 ↗MalfunctionMay 12, 2026Electrical /Electronic Property Problem
IT WAS REPORTED "ERROR 382" AND DURING INITIAL EVALUATION IT WAS FOUND THAT ERROR CODES 247 AND 382 ARE SHOWN IN THE LOG FILE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155492 ↗MalfunctionMay 6, 2026Power Problem
THE FOLLOWING WAS REPORTED: "VOLTAGE DEVIATION DURING CASE" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104562 ↗MalfunctionApr 29, 2026Insufficient Flow or Under Infusion; No Apparent Adverse Event
IT WAS REPORTED THAT "3DF ERROR, NOT WORKING AFTER MULTIPLE RESTARTS". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032714 ↗MalfunctionApr 27, 2026Gas Output Problem
THE FOLLOWING WAS REPORTED: "PRESSURE IS FLUCTUATING." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003587 ↗MalfunctionApr 16, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT ERROR MESSAGE WERE SHOWN. DURING INVESTIGATION ERROR CODES 247 AND 382 ARE DETECTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900083 ↗MalfunctionApr 9, 2026Gas Output Problem; Inflation Problem
THE FOLLOWING WAS REPORTED: "ALERTS OF HIGH PRESSURE WHEN USING DURING PROCEDURE, DESPITE THERE BEING NO REASON FOR HAVING HIGH PRESSURE. REBOOTED DURING PROCEDURE, AND WHEN LOADED BACK UP ERROR MESSAGE "SYSTEM MALFUNCTION". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834429 ↗MalfunctionApr 2, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE DEVICE CAME UP WITH ERROR CODE 240 DURING A CASE. LATER IT CAME UP WITH ERROR CODE 410. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772417 ↗MalfunctionApr 2, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE ENDOFLATOR DOES NOT WORK AND ERROR MESSAGES APPEARED ON THE SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769768 ↗MalfunctionApr 2, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT ERRORS 247 AND 382 APPEARED ON THE SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766682 ↗MalfunctionMar 30, 2026Unexpected Shutdown
IT WAS REPORTED THAT THE ENDOFLATOR STOPPED WORKING DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24721116 ↗
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
- 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
- ENDOFLATOR UI400Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE40 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.