Kii Shielded Bladed Access System CFB03Recalls & reported problems
Applied Medical Resources Corporation · Trocar · Class 2
All models of Kii Shielded Bladed Access System (8)
Data updated Oct 16, 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 00607915117627), received between Nov 9, 2016 and Aug 10, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
Device problems
- Device Contaminated During Manufacture or Shipping1
- Material Fragmentation1
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.
MalfunctionAug 10, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: "A CUSTOMER CALLED REGARDING A SHIPMENT OF STERILE ITEMS. THE PROBLEM ITEM WAS OPENED AND A HAIR WAS FOUND ON THE PRODUCT." ADDITIONAL INFORMATION VIA TELEPHONE ON (B)(6) 2022 FROM [NAME], SUPERVISOR OF SUPPLY CHAIN OPERATIONS, [FACILITY]: A HAIR FOUND INSIDE THE STERILE PACKAGING. MODEL AND LOT NUMBER WAS PROVIDED. PATIENT STATUS: NA (INCOMING INSPECTION). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15204714 ↗MalfunctionNov 9, 2016Material Fragmentation; Material Fragmentation
ENGLISH TRANSLATION DONE BY RA-QA (B)(6) - "AFTER PLACING THE TROCAR THEY HAD A LOOK WITH THE CAMERA AND THE GYNECOLOGIST NOTICED A PIECE OF PLASTIC HANGING UNDER THE BALLOON. IT DETACHED QUICKLY AND THE TROCAR REMAINED INTACT. THE MATERIAL WAS THE SAME AS THE BALLOON. PIECE IF PLASTIC WAS SAVED IN A LITTLE POT. HOWEVER THE TROCAR WAS THROWN AWAY AFTER THE PROCEDURE. LITTLE POT WITH PLASTIC IS AT THE PHARMACY TO BE PICKED UP." PATIENT STATUS - N/A. TYPE OF INTERVENTION - N/A.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6089459 ↗
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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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