ENDOFLATOR 26430520-1Recalls & reported problems
Karl Storz GmbH & Co. KG · Electronic CO2 ENDOFLATOR® SCB · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048551068793), received between Mar 11, 2019 and Jan 28, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Gas Output Problem” (2 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
- Adverse Event Without Identified Device or Use Problem3
- Gas Output Problem2
- Gradient Increase2
- Insufficient Device Problem Information2
- Gas/Air Leak1
- Mechanical Problem1
Patient problems
- Cardiac Arrest2
- No Clinical Signs, Symptoms or Conditions2
- Pulmonary Emphysema2
- Skin Disorders2
- Insufficient Information1
- Pneumothorax1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Gas Output Problem
IT WAS REPORTED THAT THE INSUFFLATOR STOPPED DELIVERING GAS, PREVENTING THE ESTABLISHMENT OF PNEUMOPERITONEUM. THE ISSUE WAS RESOLVED AFTER APPROXIMATELY 20 MINUTES, RESULTING IN PROLONGED ANESTHESIA AND SURGICAL DURATION FOR THE PATIENT. SINCE THE ANESTHESIA WAS PROLONGED, THE CASE IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201754 ↗InjuryJan 28, 2026Gas Output Problem
IT WAS REPORTED THAT THE INSUFFLATOR STOPPED DELIVERING GAS, PREVENTING THE ESTABLISHMENT OF PNEUMOPERITONEUM. THE ISSUE WAS RESOLVED AFTER APPROXIMATELY 20 MINUTES, RESULTING IN PROLONGED ANESTHESIA AND SURGICAL DURATION FOR THE PATIENT. SINCE THE ANESTHESIA WAS PROLONGED, THE CASE IS CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201753 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENTS DEVELOPED PULMONARY EMPHYSEMA DURING TWO CONSECUTIVE OPERATIONS WITH AN ENDOFLATOR. SINCE THE PATIENT SUFFERED PERMANENT DAMAGE, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: Pulmonary Emphysema; Skin Disorders
MAUDE report 21114578 ↗InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENTS DEVELOPED PULMONARY EMPHYSEMA DURING TWO CONSECUTIVE OPERATIONS WITH AN ENDOFLATOR. SINCE THE PATIENT SUFFERED PERMANENT DAMAGE, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: Pulmonary Emphysema; Skin Disorders
MAUDE report 21113920 ↗InjuryOct 24, 2024Gradient Increase; Gradient Increase
IT WAS REPORTED THAT FOUR TO FIVE MINUTES AFTER THE START OF THE LAPAROSCOPIC PROSTATECTOMY PROCEDURE A SUDDEN INCREASE IN INSUFFLATION PRESSURE OCCURRED AND WENT UP TO 28MMHG WHILE THE DEVICE WAS SET AT 12MMHG. THE PATIENT HAD A CARDIAC ARREST AND CAME BACK AFTER RESUSCITATION TREATMENT OF 5-10 MINUTES. AFTER THE PATIENT WAS STABILIZED, THE MEDICAL PROCEDURE CONTINUED AND HAD BEEN SUCCESSFULLY COMPLETED.
Patient problems: Cardiac Arrest
MAUDE report 20529474 ↗InjuryOct 24, 2024Gradient Increase; Mechanical Problem; Gradient Increase; Mechanical Problem
IT WAS REPORTED THAT FOUR TO FIVE MINUTES AFTER THE START OF THE LAPAROSCOPIC PROSTATECTOMY PROCEDURE A SUDDEN INCREASE IN INSUFFLATION PRESSURE OCCURRED AND WENT UP TO 28MMHG WHILE THE DEVICE WAS SET AT 12MMHG. THE PATIENT HAD A CARDIAC ARREST AND CAME BACK AFTER RESUSCITATION TREATMENT OF 5-10 MINUTES. AFTER THE PATIENT WAS STABILIZED, THE MEDICAL PROCEDURE CONTINUED AND HAD BEEN SUCCESSFULLY COMPLETED.
Patient problems: Cardiac Arrest
MAUDE report 20528686 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN GERMANY: FOLLOWING INSUFFLATION, CARDIAC OF THE PATIENT (LIVING PATIENT). USE OF THE SAME DEVICE IN THE AFTERNOON, CARDIAC ARREST AVOIDED.
Patient problems: Insufficient Information
MAUDE report 10793585 ↗InjuryMar 11, 2019Gas/Air Leak; Gas/Air Leak
ALLEGEDLY, DURING A GASTRIC SLEEVE PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX.
Patient problems: Pneumothorax
MAUDE report 8410539 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.