Integra® CEV605T3URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780428442), received between Feb 2, 2026 and Feb 2, 2026 — 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  A FACILITY REPORTED THAT THE TIP OF THE VERY CURVED SCISSORS INSERT FOR TUBE 5 MM DIAMETER, 310 MM LENGTH (PK 3) (CEV605T3U) DETACHED INTO THE ABDOMINAL CAVITY DURING LAPAROSCOPY, AND THE DETACHED PART WAS SUCCESSFULLY RETRIEVED. "THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE BLADE FRAGMENT WAS RETRIEVED DURING THE LAPAROSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED USING AN EQUIVALENT PAIR OF LAPAROSCOPIC SCISSORS RETRIEVED FROM A DIFFERENT SET. THE SURGICAL TIME WAS EXTENDED BY THE TIME REQUIRED TO RETRIEVE THE BLADE FRAGMENT FROM THE ABDOMEN, AS WELL AS THE TIME TO RETRIEVE THE OTHER SET FROM THE OPERATING ROOM EQUIPMENT. THE USERS DID NOT SPECIFY HOW MANY ADDITIONAL MINUTES WERE NEEDED. THEY ARE CURRENTLY UNABLE TO PROVIDE THIS INFORMATION. FINALLY, NO INFORMATION WAS PROVIDED REGARDING A RADIOLOGICAL IMAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234529 ↗