Kii® Optical Access System CTR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915124045), received between Apr 6, 2016 and Nov 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 18, 2024Break; Break

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: I WANTED TO REACH OUT AND LET YOU KNOW THAT THERE WAS AN ISSUE IN THE OPERATING ROOM THIS WEEK WITH ONE OF THE APPLIES TROCARS. 10/23 A DOCTOR BROKE AN APPLIES KII OPTICAL TROCAR OFF IN A PATIENT. AT THIS TIME, I DO NOT HAVE A REFERENCE NUMBER TO PROVIDE. I DO HAVE THE ACTUAL TROCAR. A MEDWATCH FORM WAS FILLED OUT AND SENT IN. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01NOV2024: THE PATIENT IS FINE. IT SOUNDS LIKE THE BEND/BREAK OCCURRED AT THE SHAFT. "THE TROCAR BROKE INSIDE THE PATIENT; IT WAS A CLEAN CUT." IT IS UNCLEAR THAT IF THE SHAFT BROKE, THE OBTURATOR INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. THE NUMBER(S) OF CANNULAS THAT WERE INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT IS UNCLEAR. THE BEND/BREAK OCCURRED DURING USE. IT IS UNCLEAR HOW THE TROCAR INSERTED THROUGH THE TISSUE LAYERS. ADDITIONAL INFORMATION OBTAINED FROM USER FACILITY, MEDWATCH #MW5161804 VIA EMAIL: TROCAR BROKE IN HALF INSIDE OF PATIENT. SURGEON PUTTING IN TROCAR AND WHILE INSERTING IT SHE NEEDED TO USE A LITTLE PRESSURE. TROCAR BROKE IN HALF AND STAY IN FASCIA. GENERAL SURGERY CAME TO ASSIST AND BOTH PIECES W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20713885 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: THE PROCEDURE STARTED AND THE SURGEON BEGAN TO INSERT THE TROCARS FOR THE PROCEDURE. ALL OF THE TROCARS WERE PLACED AND THE SURGEON BEGAN TO INSERT THE GRASPERS. WHILE INSERTING THE GRASPER AND MOVING THE TROCAR, NURSING STAFF AND THE SURGEON HEARD A POP AND REALIZED THAT THE TROCAR HAD BROKE IN HALF. THE PORTION OF THE TROCAR THAT WAS OUTSIDE OF THE PATIENT WAS REMOVED AND THE SURGEON BEGAN TO WORK TO GET THE OTHER HALF OF THE TROCAR OUT. THE OTHER HALF OF THE TROCAR WAS RETRIEVED USING HEMOSTATS. ANOTHER TROCAR WAS INSERTED IN A DIFFERENT LOCATION AND THE SURGERY PROCEEDED. NO OTHER THERAPIES WERE USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DATE OF EVENT IS UNKNOWN BUT IT OCCURRED IN MAY 2024. CONCOMITANT DEVICES: GRASPER, HEMOSTAT. INTERVENTION: ANOTHER TROCAR WAS INSERTED IN A DIFFERENT LOCATION AND THE SURGERY PROCEEDED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348571 ↗
• MalfunctionJun 2, 2023Break; Break

  PROCEDURE PERFORMED: DIAGNOSTIC LAPAROSCOPY. EVENT DESCRIPTION: THE BLUE SLEEVE OF THE TROCAR "SNAPPED IN HALF" DURING A TROCAR TRIAL WHEN THE SURGEON WAS TRYING TO ACCESS THE PERITONEUM. THE CANNULA BROKE INTO TWO PIECES WITH ONE PIECE STUCK IN THE SUBCUTANEOUS LAYER OF THE PATIENT'S ABDOMINAL WALL. THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE EVENT AND WAS BENT. THE BREAK/BEND OF THE CANNULA AND OBTURATOR WERE BOTH AT THE SHAFT OF THE DEVICE. NO OTHER CANNULAS WERE INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. THE BREAK OF THE CANNULA WAS CONSIDERED TO BE A CLEAN BREAK. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES, AND NOTHING WAS LEFT BEHIND. THE TROCAR WAS INSERTED IN A BACK AND FORTH "WINDSHIELD WIPER" MOTION. THE PATIENT HAD A HIGH BMI AND THE SURGEON NOTED GREAT DIFFICULTY INSERTING THE TROCAR. THE SURGEON HAD TO EXTEND THE PATIENT'S INCISION TO REMOVE THE TROCAR. NO PATIENT INJURY OCCURRED. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE SURGEON HAD TO EXTEND THE PATIENT'S INCISION TO REMOVE THE TROCAR. PATIENT STATUS: PATIENT IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048117 ↗
• MalfunctionAug 21, 2019Break; Break

  PROCEDURE PERFORMED: HYSTEROSCOPY D&C & ENDOMETRIAL ABLATION & PAP SMEAR, LAPAROSCOPY LEFT OOPHORECTOMY. EVENT DESCRIPTION: "SNAPPED DURING ENTRY, WITH MINIMAL FORCE (PER SURGEON) . BROKEN SEGMENT BECAME LODGED INSIDE PATIENT. TROCAR REMAINED INTACT". ADDITIONAL INFORMATION RECEIVED FROM USER FACILITY VIA EMAIL ON 7 AUGUST 2019: DR. [NAME] CONTINUED TO LOOK FOR THE SEGMENT LAPAROSCOPICALLY UNTIL IT WAS FOUND AND REMOVED. THE PATIENT'S CURRENT STATUS IS STABLE, DISCHARGED. THE LOT NUMBER OF THE PRODUCT IS 1317273. THE NAME OF THE PROCEDURE IS HYSTEROSCOPY D&C & ENDOMETRIAL ABLATION + PAP SMEAR, LAPAROSCOPY LEFT OOPHORECTOMY. TYPE OF INTERVENTION: SEGMENT WAS FOUND AND REMOVED. PATIENT STATUS: STABLE, DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8916042 ↗
• MalfunctionApr 6, 2016Break; Break

  PROCEDURE PERFORMED UNKNOWN. "TROCAR'S CANNULA BROKE DURING PROCEDURE." PATIENT STATUS: NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5552621 ↗