Integra® MicroFrance® CEV127TRecalls & reported problems
Integra Microfrance · Integra® MicroFrance® Head of trocar silicon valve for 5 mm trocar tip sleeve · Class 2
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 10381780103943), received between Sep 13, 2024 and Sep 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionSep 13, 2024Break; Break
THIS REPORT IS 1 OF 2 FOR THE TROCAR HEAD USED DURING THIS EVENT AND IS RELATED TO MFG NUMBER: 3003249645-2024-00046. IT WAS REPORTED THAT WHEN THE TROCAR HEAD (CEV127T) WAS PLACED ON THE ABDOMINAL WALL, IT BROKE IN TWO, LEAVING A LARGE PART IN THE ABDOMINAL WALL. THE DOCTOR MANAGED TO EXTRACT THE PIECE. THERE WAS NO SUSPECTED INJURY TO THE PATIENT. IT IS UNKNOWN WHETHER THE EVENT LEAD TO AN INCREASE IN SURGERY TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209202 ↗
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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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