SMOKE EVACUATION HIGH-FLOW TUBE SET 0620050250Recalls & reported problems
W.O.M. World of Medicine GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056702001483), received between Jun 25, 2020 and Mar 1, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Defective Device” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device3
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Death1
- Embolism/Embolus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THERE WAS A CONVERSION TO OPEN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18818488 ↗InjuryMar 1, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THERE WAS A CONVERSION TO OPEN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18818483 ↗InjuryFeb 29, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THERE WAS A CONVERSION TO OPEN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18813058 ↗InjuryJun 25, 2020Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT PATIENT PASSED AWAY DURING MEDICAL PROCEDURE. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.
Patient problems: Death; Embolism/Embolus
MAUDE report 10195727 ↗
Other Insufflator, Endoscopic Vessel Harvesting devices
- PNEUMOCLEAR FM300W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting40 reports
- PNEUMOCLEAR FM300W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting8 reports
- HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET 0620050350W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting2 reports
- HIGH-FLOW TUBE SET 0620050100W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting1 report
- HEATED HIGH-FLOW TUBE SET 0620050200W.O.M. World of Medicine GmbH · Insufflator, Endoscopic Vessel Harvesting1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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