CORE DYNAMICS CD7100GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405046001), received between Mar 21, 2016 and Mar 21, 2016.

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. 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.

• Mar 21, 2016Break; Detachment Of Device Component

  THE END-USER REPORTED THAT WHILE UTILIZING THE ENTREE II 5X90MM DISPOSABLE TROCAR KIT IN A LAPAROSCOPIC MYOMECTOMY, AND AFTER APPROXIMATELY 1.5 HOURS INTO THE PROCEDURE THE END-USER NOTICED THE 5MM ENTREE II CANNULA VALVE (COMPONENT OF THE TROCAR KIT) WAS DAMAGED AND A SMALL PART OF THE SILICONE VALVE WAS DETACHED FROM THE VALVE AND ALLEGEDLY DROPPED INTO THE PATIENT. THE PART THAT DETACHED FROM THE VALVE WAS REPORTED AS TINY IN SIZE AND TRANSPARENT AND PER THE END-USER WAS NOT REMOVED FROM THE PATIENT LEAVING AN UN-RETRIEVED DEVICE FRAGMENT WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5513653 ↗