Kii Shielded Bladed Access System CTB01Recalls & reported problems
Applied Medical Resources Corporation · Trocar · Class 2
All models of Kii Shielded Bladed Access System (8)
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 00607915123994), received between Mar 21, 2017 and Mar 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2017Mechanical Jam; Mechanical Jam
LAPAROSCOPIC OVARIAN CYSTECTOMY - "THE SURGEON TRIED TO GO IN WITH A CTF03 AND COULDN'T GAIN ACCESS. HE THEN ATTEMPTED TO GAIN ACCESS WITH THE CTB01 AFTER TRYING SEVERAL TIMES HE THEN STATED THE TROCAR WAS JAMMED "BROKEN". ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON MAY 18, 2016: "WHAT I WAS TOLD BY THE STAFF IS THE TROCAR JAMMED, MEANING THE BUTTON ON THE OBTURATOR TO ENGAGE THE SHIELD WOULD NOT SLIDE OVER. IT WAS STUCK." PATIENT STATUS: "PATIENT WAS FINE FOLLOWING PROCEDURE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6423090 ↗
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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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