MicroFrance® MCL206Recalls & reported problems
Integra Microfrance · MOUTH GAG MCL206 MORINIERE · Class 1
All models of MicroFrance (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10381780105220), received between Mar 3, 2025 and Mar 3, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam1
Patient problems
- Insufficient Information1
- Swelling/ Edema1
- Tooth Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE RIGHT DISTAL SCREW OF THE MORINIERE MOUTH GAG (MCL206) "JAMMED DURING SURGERY"; THE USER WAS UNABLE TO ADVANCE THE RACK. THE DEVICE HAD BEEN LUBRICATED, BUT "OPERATED JERKILY." THE FOLLOWING INFORMATION WAS SUBSEQUENTLY REPORTED: "COMPLICATED EXPOSURE, ASSISTANT TOO FAR AWAY, NO LIGHT IN THE MOUTH, ¿SEIZED¿ MOLINIÈRE ROBOT MOUTH OPENER, VERY DIFFICULT TO HANDLE, SCREW, UNSCREW. REQUESTS A NASOTRACHEAL INTUBATION; NEW NASOTRACHEAL INTUBATION WITH EDEMA AND BLEEDING. CLAMPING OVER PREVIOUS CLAMPING. THE MOLINIÈRE MOUTH OPENER REMAINS STUCK IN THE OPEN POSITION IN THE PATIENT, VERY DIFFICULT TO REMOVE IT. RESULT OF THE EXTEMPO: CANCER CELLS ON THE TONSILLAR PILLAR. NEW ATTEMPT AT EXPOSURE BY LUBRICATING THE MOUTH OPENER WITH THE ANESTHETISTS¿ SILICONE SPRAY. EDEMA, BLEEDING, TOOTH BREAKAGE ON THE UPPER INCISOR (21) AND GUM WOUND, EXPOSURE MADE DANGEROUS BY THE DEFECTIVE MOLINIÈRE MOUTH OPENER. NO ROBOT-ASSISTED INTERVENTION, EXCISION OF THE RIGHT TONSIL ONLY. CONSEQUENCES: TUMOR EXCISION NOT PERFORMED: CHANGE IN THERAPEUTIC MANAGEMENT (RADIOTHERAPY)." SIMPLE TONSILLECTOMY AND RADIOTHERAPY MANAGEMENT WAS PERFORMED TO COMPLETE THE PROCEDURE AS EXCISION WAS NOT P
Patient problems: Insufficient Information; Swelling/ Edema; Tooth Fracture
MAUDE report 21504668 ↗
Other GAG, MOUTH devices
- AESCULAP OM048RAesculap AG · GAG, MOUTH1 report
- Integra® Jarit® 450110RIIntegra Lifesciences Production Corporation · GAG, MOUTH1 report
- V. Mueller MO141Steris Corporation · GAG, MOUTH1 report
- MicroFrance® 7803S-2Integra Microfrance · GAG, MOUTH1 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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