Kii® Optical Dual Pack CTR12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915123505), received between Mar 17, 2020 and May 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING A DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY, AMIDST MULTIPLE INSTRUMENT EXCHANGE, ONE OF THE VALVES DETACHED FROM THE PORT AND FELL INTO THE ABDOMINAL CAVITY, IT WAS THE TRANSPARENT PLASTIC PART THAT SITS ON TOP OF THE BLACK DOUBLE DUCKBILL. THE SURGEON IN QUESTION WAS A [NAME REDACTED] WHO COMPLETED THE PROCEDURE WITH ANOTHER TROCAR. THE THEATRE CO-ORDINATOR, [NAME REDACTED] HAS KEPT THE PORT IN QUESTION AND IT IS AVAILABLE TO BE SENT TO YOU. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 5MAY23: SURGERY COMPLETED AND PATIENT TRANSFERRED TO RECOVERY AREA. ALL PARTS WERE RETRIEVED FROM THE PATIENT. CLEAR SEAL VALVE CAME OFF NOT THE ENTIRE COMPONENT OF THE PORT. ONE SIDE OF THE VALVE APPEARS TORN OFF. AT TIME OF THE ACCIDENT, LAPAROSCOPIC FENESTRATED GRASPER WAS BEING USED. PRIOR TO THE ACCIDENT, FENESTRATED GRASPER WAS USED. INTERNAL SEAL COMPONENTS WERE NOT REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. SURGEON COMPLETED THE PROCEDURE WITH ANOTHER 5 MM PORT, CTF03. TYPE OF INTERVENTION: PROCEDURE COMPLETED WITH OTHER TROCAR (CTF03). PATIENT STATUS: NO PATIENT INJURY - SURGERY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892416 ↗
• MalfunctionMar 9, 2022Fracture; Fracture

  PROCEDURE PERFORMED: LAP APPENDECTOMY. EVENT DESCRIPTION: ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 7-MAR-2022: THE PATIENT HAD 2 PREVIOUS C-SECTIONS AS THEIR ONLY PREVIOUS SURGERY. DURING THE PROCEDURE THERE WAS LOTS OF TWISTING AND PUSHING. AFTER ABOUT 15 MINUTES OF TRYING THE TROCAR ENTERED THE ABDOMEN WITH THE TIP HANGING OFF SLIGHTLY. THE REGISTRAR USED A GRASPER TO REMOVE THE TIP BEFORE IT COULD DROP INTO THE SPACE. THE TROCAR WAS THEN REMOVED AND REPLACED WITH ANOTHER WITHOUT ISSUES THE PROCEDURE WAS A LAP APPENDECTOMY. THIS WAS THE THIRD TROCAR PLACED, 2 OTHERS WERE ALREADY IN PLACE. THE TROCAR WAS INSERTED UNDER VISION. OTHER THAN THE OTHER TROCARS, THERE WERE NO INSTRUMENTS IN THE OPERATING FIELD. THE TROCAR WAS INSERTED BELOW THE UMBILICUS, LEFT ABDOMINAL. AS FAR AS THE CUSTOMER IS AWARE, THE TIP OF THE OBTURATOR DID NOT COME INTO CONTACT WITH HARD/DENSE SURFACES. IN SURGERY, THE STAFF WAS HAPPY WITH THE RETRIEVAL, HOWEVER CONFIRMATION WILL FOLLOW IF ALL PIECES WERE RETRIEVED. THE DEVICE HAS BEEN DISPOSED OF. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: UNAWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715789 ↗
• MalfunctionMar 17, 2020Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: ACCORDING TO THE STOCK CONTROLLER, THE TROCAR BROKE OFF IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL 20: THE SLEEVE AND OBTURATOR BROKE. NO PIECES FELL INTO THE PATIENT. DOCTOR PUSHED INTO THE PATIENT AND BROKE WHILE DOING IT. THE TROCAR WAS CLEANLY BROKEN. A NEW TROCAR WAS OPENED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845614 ↗