n.a. 031210-10Recalls & reported problems
Karl Storz GmbH & Co. KG · Insufflation tubing set, ENDOFLATOR 50 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048438005330), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Excessive Heating1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT THE PRODUCT IS GETTING TOO HOT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21381648 ↗
Other Tubing/tubing with filter, insufflation, laparoscopic devices
- n.a. 20400028Karl Storz GmbH & Co. KG · Tubing/tubing with filter, insufflation, laparoscopic5 reports
- EXCEL 60-6050-097Conmed Corporation · Tubing/tubing with filter, insufflation, laparoscopic3 reports
- NA 0620030301Stryker Corporation · Tubing/tubing with filter, insufflation, laparoscopic2 reports
- Valleylab SEL7010Covidien LP · Tubing/tubing with filter, insufflation, laparoscopic1 report
- EXCEL 60-6050-098Conmed Corporation · Tubing/tubing with filter, insufflation, laparoscopic1 report
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 14, 2026 · each report above links to its original FDA record
- 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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