ENDOFLATORRecalls & reported problems across all models
Karl Storz GmbH & Co. KG · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 241
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 3 models of ENDOFLATOR by Karl Storz GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2019 and Sep 30, 2026 — classified as 39 injuries, 202 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (58 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
Reports received per month, all models
Most reported ENDOFLATOR problems
Device problems
- Insufficient Device Problem Information58
- No Apparent Adverse Event34
- Defective Component33
- Gas Output Problem29
- Output Problem28
- Pressure Problem17
- Unexpected Shutdown16
- Electrical /Electronic Property Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- Insufficient Information48
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Cardiac Arrest2
- Foreign Body In Patient2
- Pulmonary Emphysema2
- Skin Disorders2
- Bowel Burn1
ENDOFLATOR models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOFLATOR UI500INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE193 reports
- ENDOFLATOR UI400INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE40 reports
- ENDOFLATOR 26430520-1INSUFFLATOR, LAPAROSCOPIC8 reports
Recent ENDOFLATOR adverse event reports
The 15 most recent reports across all models, 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 13, 2026Gas Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235148 ↗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 ↗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 ↗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 ↗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 ↗
Other Karl Storz GmbH & Co. KG products
All Karl Storz GmbH & Co. KG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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