Integra® MicroFrance® CEV525Recalls & reported problems
Integra Microfrance · Integra® MicroFrance® Johann fenestrated forceps, 20 mm jaws, 5 mm diameter, 345 mm length, axial handle · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780093749), received between Jul 22, 2025 and Apr 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bowel Burn1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE FORCEPS CEV525 FENESTRATED 20MM JAWZ (CEV525), " BROKE AT THE JAW FOR NO APPARENT REASON. THE BROKEN AND DETACHED PIECE OF FORCEPS REMAINED MOMENTARILY INSIDE THE PATIENT'S ABDOMEN." IT WAS REPORTED THAT THE BROKEN PIECES WERE RETRIEVED, AND THERE WERE NO CONSEQUENCES TO THE PATIENT, TIME, OR MATERIAL LOSS. NO JURY OR DEATH REPORTED.
Patient problems: Bowel Burn
MAUDE report 24815814 ↗MalfunctionDec 4, 2025Break; Break
A FACILITY REPORTED THAT TWO PIECES OF THE FORCEPS CEV525 FENESTRATED 20MM JAWZ (CEV525) SHEATH BECAME LOOSE AND FELL INTO THE PATIENT'S ABDOMEN. IT IS UNKNOWN IF THERE WAS A PATIENT'S INJURY, DEATH, OR SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720825 ↗MalfunctionJul 22, 2025Break; Break
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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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