Kii Fios First Entry CTF31Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915124823), received between Feb 10, 2017 and Feb 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 10, 2017Bent; Fracture; Bent; Fracture

  LAP PERITONEAL DIALYSIS CATHETER INSERTION - "[THE SURGEON] NEEDED A LONGER TROCAR FOR A CATHETER INSERTION. HE WANTED LONG 8 BUT SINCE WE DONT HAVE HE OPTED FOR AN 11MMX150MM. WHEN INSERTING THE TROCAR THE CANNULA BENT IN HALF. HE PULLED IT OUT AND CALLED FOR AN [COMPETITOR] TO PERFORM THE CASE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON (B)(6) 2017: WAS NOT SURE IF THE 8MM INCISION EXTENDED TO ACCOMMODATE AN 11MM TROCAR. DURING INSERTION, IT WAS SAID THAT EXCESSIVE FORCE WAS NOT USED ACCORDING TO THE SURGEON, BUT USING STANDARD MORE TWIST LESS PUSH APPROACH. PRODUCT WAS RETURNED IN THE CONDITION IT WAS IN AFTER THE CASE. TYPE OF INTERVENTION: "[COMPETITOR] TO PERFORM THE CASE." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6324344 ↗