Kii Optical Access System CFR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915122294), received between Aug 9, 2024 and Oct 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: AFTER INCISION THE TROCAR WAS BY ROTATING MOVEMENTS AND APPROPRIATE PRESSURE PLACED IN THE ABDOMINAL WALL. BY PASSING THE TISSUE, A PEACE OF THE SLEEVE WAS BROKEN OFF. THE SURGEON REMOVED THE PEACE OUT OF THE PATIENT BY USING A GRASPER. THE SURGEON FIRST REMOVED THE TROCAR, THAN HE USED A GRASPER TO REMOVE THE PEACE OUT OF THE PATIENTS ABDOMEN. THAN HE OPEN A NEW TROCAR AND PLACED IT WITHOUT PROBLEMS. NO CLINICAL IMPACT. TYPE OF INTEVENTION: OPEND A NEW TROCAR AND PLACED IT WITHOUT PROBLEMS. PATIENT STATUS: NO INJURY OR ILLNESS OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477220 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: (B)(4), COMPLAINT 1 OF 2. (MDR REPORT ID: 2027111-2024-00782). (B)(4), COMPLAINT 2 OF 2. (MDR REPORT ID: 2027111-2024-00819). IN (B)(6) 2024, TWO DIFFERENT, DR. [NAME] ENCOUNTERED ISSUES WITH A SPECIFIC TROCAR (CFR01) DURING LAPAROSCOPIC CHOLECYSTECTOMY (LAB CHOLE) PROCEDURES. SURGEON REPORTED THAT THE TROCAR BROKE DURING THE SURGICAL CASES. A RESULT OF THESE INCIDENTS, THE SURGEON STOPPED USING THE CFR01 TROCAR CATALOG AND HAVE A SUBSTANTIAL REMAINING INVENTORY OF THIS PRODUCT. THEY WOULD LIKE TO UNDERSTAND WHY THE TROCAR BROKE DURING THE PROCEDURES SO THEY CAN DETERMINE IF THERE ARE ANY ISSUES WITH THE DESIGN OR MANUFACTURING OF THIS PARTICULAR DEVICE. THERE IS NO IMPACT CLINICAL IMPACT ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD TEAM ON SEPTEMBER 4, 2024 THROUGH EMAIL: YES, THERE WERE TWO INCIDENTS INVOLVING CFR01 WITH TWO DIFFERENT SURGEONS. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD TEAM ON SEPTEMBER 23: THE SURGEON EXPERIENCED THE SAME TYPE OF TROCAR BREAKAGE. TYPE OF INTERVENTION: THEY REPLACED THE DEVICE WITH OTHER TROCAR FROM DIFFERENT MANUFACTURE. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138232 ↗
• MalfunctionAug 9, 2024Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: IN MAY 2024, TWO DIFFERENT SURGEONS DR. [NAME] AND DR. [NAME], ENCOUNTERED ISSUES WITH A SPECIFIC TROCAR (CFR01) DURING SEPARATE LAPAROSCOPIC CHOLECYSTECTOMY (LAB CHOLE) PROCEDURES. BOTH SURGEONS REPORTED THAT THE TROCAR BROKE DURING THE SURGICAL CASES. AS A RESULT OF THESE INCIDENTS, THE SURGEONS STOPPED USING THE CFR01 TROCAR CATALOG AND HAVE SUBSTANTIAL REMAINING INVENTORY OF THIS PRODUCT. THEY WOULD LIKE TO UNDERSTAND WHY THE TROCAR BROKE DURING THE PROCEDURES SO THEY CAN DETERMINE IF THERE ARE ISSUES WITH THE DESIGN OR MANUFACTURING OF THIS PARTICULAR DEVICE. TYPE OF INTERVENTION: THEY REPLACED THE DEVICE WITH ANOTHER TROCAR FROM DIFFERENT MANUFACTURER. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955908 ↗