Kii Fios Dual Pack CTF35Recalls & reported problems
Applied Medical Resources Corporation · Trocar · Class 2
All models of Kii Fios Dual Pack (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915129880), received between May 18, 2016 and Feb 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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 Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2023Material Fragmentation; Material Fragmentation
PROCEDURE PERFORMED: LAP HYSTERECTOMY . EVENT DESCRIPTION: TRANSLATION DURING SURGERY AT 8/12, A TROCAR 11X100 KII FIOS DUAL PACK FROM APPLIED (REF: CTF35) WAS NOTED TO HAVE A DEFECT. THE TIP OF THE TROCAR PIN HAS AN ABNORMAL SHAPE, SO IT COULD NOT BE USED IN THE PROCEDURE. THE TIP OF THE PIN APPEARS "MELTED" INTERVENTION: ANOTHER TROCAR. PATIENT STATUS: N/A.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16330402 ↗MalfunctionMay 18, 2016Material Fragmentation; Material Fragmentation
LAP. TAPP (HERNIA REPAIR) - "A PIECE OF THE SEAL FELL INTO THE SITUS AFTER ATRAUMATIC INSERTION OF THE DIVICES. THE PIECE OF THE SEAL, COULD BE RETRIEVED." PATIENT STATUS - "OK".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5665566 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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