Kii Shielded Bladed Dual Pack CTB35Recalls & reported problems
Applied Medical Resources Corporation · Trocar · Class 2
Data updated Oct 18, 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 00607915129897), received between Apr 3, 2017 and Aug 5, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation3
- Break1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024Break; Material Fragmentation; Break; Material Fragmentation
PROCEDURE PERFORMED: COELIO SIGMOIDECTOMY. EVENT DESCRIPTION: [TRANSLATION] DURING A COELIO SIGMOIDECTOMY: WHEN THE TROCARS WERE REMOVED AT THE END OF THE OPERATION, THE END OF THE TROCAR WAS FOUND TO BE DAMAGED: BROKEN, BURNT? THE OPTIC (30 MM VIDEO LAPARASCOPE) WAS PLACED IN THIS TROCAR HAD MICROCHIPS FALLEN INTRA-ABDOMINALLY? PATIENT STATUS: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19913118 ↗MalfunctionSep 15, 2022Material Fragmentation; Material Fragmentation
PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: "TROCAR KIT #1 IS USED. WHEN TROCAR #11 IS USED, A PIECE OF THE SAME MATERIAL FALLS INTO THE PATIENT, AND THE PIECE IS SUCCESSFULLY EXTRACTED." PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE PIECE WAS SUCCESSFULLY EXTRACTED. PATIENT STATUS: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 15433317 ↗MalfunctionApr 3, 2017Material Fragmentation; Material Fragmentation
PROCEDURE PERFORMED: APPENDECTOMY. INCIDENT DESCRIPTION: DURING APPENDECTOMY UNDER LAPAROSCOPY, A PIECE OF PLASTIC WAS FOUND IN THE ABDOMINAL CAVITY OF THE PATIENT. THIS PLASTIC HAS THE SAME TEXTURE OF THE VALVE OF THE TROCAR. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6455234 ↗
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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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