Integra® MicroFrance® CEV9625-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780097075), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 injury.

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.

• InjuryFeb 16, 2026Break

  A FACILITY REPORTED THAT DURING A ROBOTIC SEGMENTECTOMY, RETRIEVAL OF A COMPRESS THE INSERT CEV9625-1 FENESTRATED 450MM (CEV9625-1), THE JAWS OF THE FENESTRATED FORCEPS BROKE. THE JAWS DETACHED FROM THE TUBE, AND A SCREW BROKE. IT WAS REPORTED THAT THE SMALL SCREW THAT CAME WITH THE FORCEPS FELL ONTO THE OPERATING TABLE AFTER BREAKING, BUT IT COULD NOT GUARANTEE THAT ANYTHING FELL INTO THE PATIENT'S CHEST. THE FACILITY COULD NOT DETERMINE IF ANY PIECES, OTHER THAN THOSE THEY DELIVERED WITH THE FORCEPS, HAD FALLEN OFF, AND WANTED EXPERT ASSESSMENT TO DETERMINE IF THE FORCEPS WERE INTACT. "WE PERFORMED A COMPLETE EXAMINATION, INCLUDING A THOROUGH IRRIGATION OF THE PATIENT'S CHEST TO TRY AND LOCATE ANY POSSIBLE FRAGMENTS, BUT WE COULDN'T IDENTIFY ANYTHING. THE PATIENT UNDERWENT STANDARD POST-OPERATIVE X-RAYS. UNFORTUNATELY, I CANNOT CONFIRM THIS BECAUSE IF THERE IS A FRAGMENT, IT IS VERY SMALL AND PROBABLY INVISIBLE ON THE X-RAY. ESPECIALLY SINCE PATIENTS ARE STAPLED DURING THE PROCEDURE, MAKING IT DIFFICULT TO DIFFERENTIATE BETWEEN STAPLES AND ANY POTENTIAL STAPLE FRAGMENTS." NO PATIENT INJURY OR DEATH WAS REPORTED; HOWEVER, A FIVE-MINUTE SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24355948 ↗