Kii® Blunt Tip Access System C0R95Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915127602), received between Mar 2, 2017 and Sep 11, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NA (BEFORE USE). EVENT DESCRIPTION: PLASTIC ATTACHMENT PIECE CRACKED OFF DISPOSABLE LAPAROSCOPIC TROCAR DURING SET-UP. NO CONTACT WITH PATIENT, ITEM REMOVED FROM SURGICAL FIELD. 1 ITEM IMPACTED, NOT A REPEAT ISSUE. TYPE OF INCIDENT/PROBLEM: DEFECT (DETECTED BEFORE USE) LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES, HOSPITAL SUBMITTED MDIP (B)(4) COMPLAINT SAMPLE IS RETAINED FOR RETURN AND IS CLEAN/NOT USED PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 26APR2023 FROM DISTRIBUTOR: THE EVENT DATE SHOULD HAVE BEEN (B)(6) 2023. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725690 ↗
• MalfunctionAug 3, 2021Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: NURSE UNIT MANAGER SAID THAT THE TROCAR SNAPPED UPON INSERTION. DEVICE HAS BEEN RETAINED TO SHIP BACK FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [APPLIED MEDICAL REPRESENTATIVE] ON (B)(6) 2021: I WAS TOLD BY THE NURSE UNIT MANAGER AT THE TIME OF NOTIFICATION THAT THE PATIENT WAS FINE AND NO HARM DONE. PATIENT STATUS: THE PATIENT WAS FINE AND NO HARM DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268959 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE INTERIOR VALVE OF THE C0R95 BECAME DISLODGED FROM THE PORT AND WENT INTO THE ABDOMEN DURING THE PROCEDURE. THE PART WAS OBTAINED AND THERE WAS NO HARM TO THE PATIENT. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445773 ↗
• MalfunctionApr 14, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP HERNIA. INCIDENT DESCRIPTION: "FEEDING MESH DOWN THROUGH SEAL WITH A [COMPETITOR] GRASPER, THE RUBBER ON THE SEAL DISLODGED, THE SURGEON IDENTIFIED THE PIECE SITTING IN THE INCISION AND RETRIEVED IT SAFELY." TYPE OF INTERVENTION: "THE SURGEON IDENTIFIED THE PIECE SITTING IN THE INCISION AND RETRIEVED IT SAFELY." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6494218 ↗
• MalfunctionMar 2, 2017Physical Resistance; Physical Resistance

  LAP PROSTATE- "SURGEON COMPLAINING OF CAMERA DRAG THROUGH C0R95 PORT. DRAG NOTED WHEN MOVING SCOPE INTO AND OUT OF THE PORT. CAMERA IS OLYMPUS ENDOEYE 10MM. SCOPE CLEANING SOLUTION USED ALSO." PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372807 ↗