Integra® MicroFrance® CEV738T5Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780095378), received between Nov 12, 2024 and Jul 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403744 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE DIA 5 MM TUNGSTEN "NEEDLE HOLDER (CEV738T5) BROKE DURING SURGERY. FRAGMENTS OF BROKEN JAWS WERE DISSEMINATED IN THE PATIENT'S ABDOMEN. ALL FRAGMENTS WERE SEARCHED AND REMOVED TO AVOID ANY DAMAGE TO THE PATIENT." IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY SUPERIOR TO 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249011 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT THE JAW OF THE DIA 5 MM TUNGSTEN NEEDLE HOLDER (CEV738T5) BROKE IN THE BELLY OF A PATIENT. THERE WAS A 30-MINUTE INCREASE OF SURGERY TIME, TO FIND THE BROKEN PIECE IN THE PATIENT'S ABDOMEN. ALL PARTS WERE REPORTEDLY REMOVED. THE OPERATING ROOM TEAM CHANGED THE NEEDLE HOLDER IN ORDER TO COMPLETE THE INTRA-ABDOMINAL SUTURES. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095179 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT THE DIA 5MM TUNGSTEN NEEDLE HOLDER (CEV738T5) BROKE DURING USE. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. IT IS UNKNOWN WHETHER ANY INJURY OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20850282 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT THE DIA 5MM TUNGSTEN NEEDLE HOLDER (CEV738T5) BROKE DURING USE AND A FRAGMENT FELL INTO THE PATIENT. THE DOCTOR INDICATED THAT THE FAILURE OCCURRED DURING SUTURE, WITHOUT ANY CONSTRAINTS APPLIED ON THE INSTRUMENT. IT IS UNKNOWN WHETHER FRAGMENTS WERE REMOVED. NO INJURY, DEATH OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667649 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT THE DIA 5MM TUNGSTEN NEEDLE HOLDER (CEV738T5) BROKE DURING USE. THERE WAS NO RESPONSE RECEIVED REGARDING CONTEXT OR POTENTIAL FRAGMENTS, NOR ABOUT NUMBER OF USES. NO INJURY, DEATH OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666583 ↗