Kii Fios First Entry CFF74Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915117665), received between Jun 13, 2016 and Jun 13, 2016 — 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. 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.

• MalfunctionJun 13, 2016Material Fragmentation; Material Fragmentation

  APPENDICITIS - "CHARGE NURSE STATED THAT DR. (B)(6) HAD A DIFFICULTY ADVANCING THE 45MM STAPLER THROUGH THE 12MM TROCAR, THEY HEARD A POPPING SOUND THEN THE INSTRUMENT WAS ABLE TO PASS THROUGH THE TROCAR, AFTER THE APPENDIX WAS TAKEN OUT, THEY GAVE PATIENT THE TRACAR AND A SMALL PIECE OF PLASTIC THEY THOUGHT WAS A PART THAT BROKE OFF DURING THE POPPING SOUND, AFTER INSPECTING THE TROCAR, THE SMALL BLACK PLASTIC WAS CONFIRMED AS A PART OF THE TROCAR'S AIR LOCKING SYSTEM AND NO OTHER PARTS ARE MISSING FROM THE TROCAR, SURGEON AND SCRUB TECH ALSO CONFIRMED THE PIECE AND THAT NO OTHER PARTS ARE LEFT INSIDE THE PATIENT." PATIENT STATUS - GOOD CONDITION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5720868 ↗