Integra® MicroFrance® CEV605-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780094159), received between Dec 29, 2024 and Aug 27, 2026 — classified as 1 injury, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Break

  A facility reported that during a robot-assisted left segmental ureterectomy, the laparoscopic scissors broke inside the operative cavity. They were removed through the trocar without any difficulty; however, it is impossible to determine whether a metallic fragment of the scissors remained within the surgical site. The proper functioning of the scissors had been verified immediately preoperatively by the scrub nurse. Visual inspection of the abdominal cavity did not reveal any lesions; however, an infectious risk must be taken into consideration if a metallic fragment remained in the abdomen. The instrument was removed from the surgical field; upon inspection, a missing component was identified at the tip of the scissors and reported. The abdominal cavity was irrigated and suctioned, followed by a meticulous visual inspection of the surgical site. No injury, death, or surgical delay was reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50477678 ↗
• MalfunctionOct 27, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393402 ↗
• MalfunctionDec 29, 2024Break; Break

  IT WAS REPORTED THAT ONE OF THE BLADES OF THE LAPAROSCOPIC SCISSORS/350MM DIA 5MM SCISSORS INSERT (CEV605-1) BROKE IN THE PATIENT'S ABDOMINAL CAVITY. THERE WAS NO IMMEDIATE CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT THE DELAY IN INTERVENTION TO REPLACE THE DEVICE AND RECOVER THE MISSING PART FROM THE PATIENT WAS INFERIOR TO 30 MINUTES. THE ENTIRE INSTRUMENT WAS REPORTEDLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032274 ↗