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Kii Fios First Entry CFF31Recalls & reported problems

Applied Medical Resources Corporation · Trocar · Class 2

All models of Kii Fios First Entry (18)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915119942), received between Dec 14, 2017 and Dec 14, 2017 — 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 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 14, 2017Material Fragmentation; Material Fragmentation

    EVENT DESCRIPTION: THE INTERNAL VALVE OF THE TROCAR WAS TORN OFF WITHOUT HAVING FORCED + A PIECE OF VALVE WAS FOUND INSIDE THE PATIENT DURING THE PROCEDURE ORIGINAL: LA VALVE INTERNE DU TROCART S'EST ARRACHÉE SANS AVOIR FORCÉ + UN MORCEAU DE VALVE A ÉTÉ RETROUVÉ À L'INTÉRIEUR DU PATIENT PENDANT L'INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7118775 ↗

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Sources and updates

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