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Insufflator F104Recalls & reported problems

W.O.M. World of Medicine GmbH · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056702000011), received between May 23, 2019 and May 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash1
  • Noise, Audible1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 23, 2019Leak/Splash; Noise, Audible; Leak/Splash; Noise, Audible

    ACCORDING TO THE REPORTER, PRE OPERATIVELY, DURING DEMONSTRATION, ONCE THE DEVICE WAS CONNECTED BETWEEN THE GAS TANK AND THE GAS RECEPTACLE AND THE USER OPENED THE GAS VALVE, THE INSUFFLATOR HAD A SOUND OF LEAKING INSIDE ITSELF AND THE DEVICE HAD A HIGH PRESSURE LEAK. THE OPERATOR PERFORMED TROUBLE SHOOTING FOUND THE HIGH PRESSURE CONTROL DEFECTIVE. THE HIGH PRESSURE CONTROL WAS REPLACED AND ALL WAS TESTED WITHOUT ISSUES. THE PROCEDURE WAS CONVERTED TO A CHOLECYSTECTOMY DUE TO THE INSUFFLATOR WAS NOT WORKING.

    Patient problems: No Code Available

    MAUDE report 8638800 ↗

Other Insufflator, Laparoscopic devices

All Insufflator, Laparoscopic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.