Kii® Blunt Tip Access System C0R85Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915118549), received between Feb 2, 2016 and Oct 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Material Separation; Material Separation

  PROCEDURE PERFORMED: LAP HERNIA. EVENT DESCRIPTION: "TURTLENECK" WOULD NOT LOCK. UPON REVIEW, STAFF NOTICED THAT IT WAS MISSING AN "O" RING. DR. [NAME] WAS THE SURGEON. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FOR MEDWATCH # (B)(4) ON 23SEP2022: HUSSAN TROCAR IN PATIENT FOR PROCEDURE. DOCTOR SPONGE PULLED OUT THROUGH HUSSAN TROCAR. TROCAR BECAME DISLODGED. TROCAR REINTRODUCED INTO PATIENT AND LOCKING MECHANISM WOULD NOT LOCK. TROCAR REMOVED FROM FIELD AND INSPECTED. TROCAR FOUND TO BE MISSING A PLASTIC O RING FROM INSIDE THE TURTLENECK PIECE OF TROCAR. CAVITY SEARCHED BY MD. OPERATIONG ROOM SEARCHED BY STAFF. MISSING PIECE NOT LOCATED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM USER FACILITY ON 28SEP2022: UNABLE TO ANSWER ACCURATELY IF THE ENTIRE SEAL HOUSING OR CAP DETACHED. UNSURE OF WHAT TURTLENECK IS. THIS MISSING PIECE WAS AN INNER PIECE. NO PICTURES OF DEVICE ARE AVAILABLE. PATIENT STATUS: DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538100 ↗
• MalfunctionOct 12, 2016Detachment Of Device Component; Detachment Of Device Component

  MEDWATCH REPORT. "TOP PIECE FELL OFF REPEATEDLY. WOULD NOT STAY CLICKED IN. THE PROCEDURE WAS COMPLETED WITH AN IDENTICAL ITEM." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? NOT KNOWN. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)" ADDITIONAL INFORMATION RECEIVED VIA E-MAIL FROM THE CUSTOMER ON SEPTEMBER 14, 2016: THE STAFF DID NOT INDICATE HOW THE SEAL HOUSING FELL OFF OR IF IT WAS EASILY REMOVED. NO INDICATION WAS MENTIONED FROM THE STAFF REGARDING WHETHER OR NOT THE TABS WERE BEING PINCHED AT THE TIME OF BREAKAGE. THE DEVICE IS AVAILABLE FOR RETURN FOR EVALUATION AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6024839 ↗
• MalfunctionMay 18, 2016Break; Break

  LAP. CHOLE. - "AT THE END OF PROCEDURE, SURGEON, TO TAKE OFF A GAUZE USED DURING PROCEDURE, CAUGHT IT WITH JOHANN GRASPER AND TOOK IT OFF THROUGH OUR C0R85 TROCAR. AFTER TROCAR EXTRACTION HE REALIZED THAT PART OF TIP TROCAR (FRAGMENT OF ABOUT 5MM) WAS BROKEN. HE COULD NOT FIND ANYMORE PLASTIC PIECE AND HE DOESN'T KNOW IF IT REMAINED IN PATIENT ABDOMEN. EVENT WAS REPORTED TO ITALIAN MINISTRY OF HEALTH AS "INCIDENT." EVENT SAMPLE IS AVAILABLE BUT WE NEED TO WAIT LEGAL TIME BEFORE ORGANIZE ITS PICK UP (AND IF MINISTRY DECIDE NOT TO CHECK IT BY HIMSELF)." PATIENT STATUS - UNKNOWN.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5665537 ↗
• MalfunctionFeb 2, 2016Detachment Of Device Component; Detachment Of Device Component

  LAP CHOLE - "TROCAR WENT WITHOUT ANY ISSUE, THEN THE TOP PORTION BROKE (OUTSIDE THE BODY) AS THE CAMERA WAS BEING INSERTED. DR (B)(6) PERFORMED THIS PROCEDURE." PATIENT STATUS - PATIENT IS FINE. MEDWATCH REPORT: LAP CHOLECYSTECTOMY ON (B)(6) 2016 - "TROCAR WAS INSERTED WITHOUT DIFFICULTY. WHEN THE SCOPE WAS PLACED INTO THE TROCAR THE TOP OF THE TROCAR FELL APART. NO HARM TO THE PATIENT, NO FRAGMENTS OR FOREIGN BODIES NEEDED TO BE RETRIEVED FROM INSIDE THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5405764 ↗