CORE DYNAMICS CD612Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405045861), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 2, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE CD612, ENII 5/10/12MM VAL FLPTOP RDCR WAS BEING USED ON 13JUN24 DURING AN ENDOCHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THE DISPOSABLE PART OF OUR CORE TROCARS FELL INTO THE ABDOMINAL CAVITY DURING THE PROCEDURE. IT WAS SEEN RIGHT AWAY AND RETRIEVED.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THE WAS A 5-MINUTE DELAY REPORTED AND ¿SINCE IT WAS SEEN AND RETRIEVED RIGHT AWAY, THERE WAS NO IMPACT ON THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655339 ↗