n.a. 20400028Recalls & reported problems
Karl Storz GmbH & Co. KG · CO2 High Pressure Tube, Pin-Index · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551067574), received between Jun 18, 2024 and Nov 4, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak2
- Temperature Problem2
- Device Handling Problem1
- Leak/Splash1
Patient problems
- Burn(s)2
- Discomfort2
- Myocarditis2
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024Leak/Splash; Device Handling Problem; Leak/Splash; Device Handling Problem
ADDITIONAL INFORMATION: ROUTINE LAP SPAY: PLACED THE TWO PORTS, SUSPENDED THE R OVARIE, PARTIALLY CAUTERISED THE PLEXUS AND GOT TO CUTTING OFF THE UTERINE HORN OFF. NO CONCERNS WITH GAS UP UNTIL THIS POINT, THEN ENCOUNTERED ISSUES WITH THE GAS CYLINDER, POPPING SOUND HEARD ONCE ONLY, THEN HISSING SOUND- MULTIPLE STAFF MEMBERS TRIED TO FIX IT. CHANGED GAS CYLINDER BUT PROBLEM CONTINUED TO PRESENT ITSELF. PROCEDURE ABORTED, PATIENT WELL ON RECOVERY. OPERATION CONTINUED ON THE 30TH AFTER IT HAD BEEN FIXED.
Patient problems: Insufficient Information
MAUDE report 20605341 ↗InjuryJun 27, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT A NURSE RECEIVED A GAS BURN TO THEIR HAND WHILE CHANGING THE CO2 BOTTLE.
Patient problems: Burn(s)
MAUDE report 19629230 ↗InjuryJun 27, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED THAT A NURSE RECEIVED A GAS BURN TO THEIR HAND WHILE CHANGING THE CO2 BOTTLE.
Patient problems: Burn(s)
MAUDE report 19628921 ↗InjuryJun 18, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT CO2 GAS WAS LEAKING FROM THE HOSE YOKE CONNECTION RESULTING IN 3 MEMBERS OF STAFF FEELING LIGHT HEADED AND PHONING 111 (NATIONAL HEALTH SERVICE) FOR ADVICE.
Patient problems: Discomfort; Myocarditis
MAUDE report 19558492 ↗InjuryJun 18, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT CO2 GAS WAS LEAKING FROM THE HOSE YOKE CONNECTION RESULTING IN 3 MEMBERS OF STAFF FEELING LIGHT HEADED AND PHONING 111 (NATIONAL HEALTH SERVICE) FOR ADVICE.
Patient problems: Discomfort; Myocarditis
MAUDE report 19558488 ↗
Other Tubing/tubing with filter, insufflation, laparoscopic devices
- EXCEL 60-6050-097Conmed Corporation · Tubing/tubing with filter, insufflation, laparoscopic3 reports
- NA 0620030301Stryker Corporation · Tubing/tubing with filter, insufflation, laparoscopic2 reports
- EXCEL 60-6050-098Conmed Corporation · Tubing/tubing with filter, insufflation, laparoscopic1 report
- Valleylab SEL7010Covidien LP · Tubing/tubing with filter, insufflation, laparoscopic1 report
- n.a. 031210-10Karl Storz GmbH & Co. KG · Tubing/tubing with filter, insufflation, laparoscopic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.