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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All Insufflator, Endoscopic Vessel Harvesting devices →

Sources and updates

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