Kii Fios First Entry CFF01Recalls & reported problems
Applied Medical Resources Corporation · Trocar · Class 2
All models of Kii Fios First Entry (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915123147), received between Jun 6, 2023 and Aug 11, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212726 ↗MalfunctionJun 1, 2026Material Fragmentation
PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL OVARIAN CYSTECTOMY. EVENT DESCRIPTION: ISSUE: TROCAR TIP BROKEN DURING OPERATION. TROUBLESHOOTING: SEARCH INTO ABDOMINAL CAVITY N IRRIGATION 3L NS. PHYSICAL ISSUE: BROKEN TROCAR CAN BE SEEN. BROKEN PART CAN HURT PT INTERNAL ORGANS. INTERVENTION: TROUBLESHOOTING: SEARCH INTO ABDOMINAL CAVITY N IRRIGATION 3L NS. PATIENT STATUS: PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350492 ↗MalfunctionJun 6, 2023Material Fragmentation; Material Fragmentation
PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: PER THE REP, THE TIP OF THE TROCAR BROKE OFF INTO THE PATIENT. PER THE PICTURES PROVIDED IT APPEARED THAT THE TIP WAS ABLE TO BE RETRIEVED FROM THE PATIENT. PATIENT SEEMS TO BE FINE. PATIENT STATUS: "PATIENT SEEMS TO BE FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073310 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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