Kii Fios Dual Pack CTF12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915125707), received between Apr 13, 2016 and Aug 11, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213012 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC NISSEN FUNDOPLICATION. EVENT DESCRIPTION: WHEN THE SURGEON PUT GRASPER IN TROCAR CTF12 THE TRANSPARENT PART OF THE KII TROCAR SEAL FALLEN IN THE ABDOMINAL. ACTION BEING PERFORMED WHEN THE EVENT OCCURED: GRASPER [BRAND NAME PRODUCT], 5MM WITH [BRAND NAME PRODUCT]. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 6NOV2025: ALL PIECES RETRIEVED FROM PATIENT. COMPONENT APPEAR TO BE TORN OFF. NO REMOVAL OR CUT OF THE COMPONENTS IN ORDER TO INSPECT THE DAMAGED COMPONENT. DURING EVENT JUST GRASPER AND [BRAND NAME PRODUCT] WERE USED. INTERVENTION: USE ANOTHER TROCAR, [BRAND NAME PRODUCT], PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572259 ↗
• MalfunctionNov 14, 2024Break; Fracture; Break; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY EVENT DESCRIPTION: DEVICE WAS BEING INTRODUCED THROUGH THE ABDOMINAL WALL. 2ND PORT BEING PLACED FROM THE DUAL PACK. EXPERIENCED SURGEON PLACING ANCILLARY PORT. THE DEVICE BROKE AT THE START OF INSERTION. OBTURATOR AND CANNULA APPEAR TO BE BROKEN. NO CLINICAL IMPACT. INTERVENTION: ANOTHER CTF03 WAS USED. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689018 ↗
• InjuryAug 23, 2024Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: [TRANSLATION] "THE OPERATING ROOM REPORTED AN INCIDENT INVOLVING A THREADED TROCAR. DEFECT: FOREIGN BODY (RUBBER?) PRESENT IN THE TROCAR. THE PATIENT WAS GIVEN ANTIBIOTIC PROPHYLAXIS TO PREVENT THE RISK OF INFECTION. ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. THE TROCAR WAS KEPT FOR EXPERT EXAMINATION. CAN YOU TELL ME IF YOU'VE RECEIVED ANY OTHER REPORTS ON THIS REFERENCE/BATCH, OR IF THE ANALYSIS OF THE PRODUCTION BATCH MENTIONS ANY DEVIATIONS?" CLOSING LETTER REQUESTED. ADDITIONAL INFORMATION RECEIVED FROM SALES MANAGER VIA EMAIL ON 31JUL2024: [TRANSLATION]: "BY THE WAY, THE PATIENT IS DOING VERY WELL (IF ANYONE IS INTERESTED) AND HAS HAD NO SECONDARY INFECTIONS."- DOCTOR INTERVENTION: ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS: A PREVENTIVE ANTIBIOTIC TREATMENT WAS MADE BY THE SURGEON, PATIENT IS DOING WELL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047042 ↗
• MalfunctionApr 22, 2022Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: OBTURATOR TIP BROKE BUT DID NOT BREAK OFF IE REMAINED IN ONE PIECE. THE TIP BROKE HALFWAY WITHIN THE ABDOMINAL WALL WHILST ENTERING - BENT TIP WAS VISUALIZED LAPAROSCOPICALLY HENCE REMOVED. SURGEON REMOVED DAMAGED TROCAR AND REPLACED WITH METAL TROCAR. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: SURGEON REMOVED DAMAGED TROCAR AND REPLACED WITH METAL TROCAR. PATIENT STATUS: NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190914 ↗
• MalfunctionMar 25, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP LOW ANTERIOR RESECTION. EVENT DESCRIPTION: SURGEON NOTICED A FRAGMENT OF PLASTIC IN THE ABDOMEN. AN OBTURATOR WAS REMOVED AFTER ENTRY OF A KII TROCAR AND NOTICED THE HELIX TIP SEEMED TO BE BENT OR BROKEN AND THE SURGEON ASKED TO SENT THIS OFF FOR INVESTIGATION TO AM. THE FRAGMENT WAS NOT REMOVED FROM THE ABDOMEN, THOUGHT TO BE FROM THE DAMAGED OBTURATOR. NO SUGGESTION WAS MADE WHY IT WAS DAMAGED, NO ABNORMAL OBSERVATIONS BEFORE OR DURING TROCAR ENTRY AND NORMAL FUNCTION OF KII TROCARS DURING THE PROCEDURE. INTERVENTION: THE FRAGMENT WAS NOT REMOVED FROM THE ABDOMEN, THOUGHT TO BE FROM THE DAMAGED OBTURATOR. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13913353 ↗
• MalfunctionJan 6, 2022Break; Break

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] DURING PLACEMENT OF THE 5 MM TROCAR, IT BROKE IN 2 IN THE ABDOMINAL WALL, IN HORIZONTAL DIRECTION. THE ABDOMINAL WALL OF THE PATIENT WAS CERTAINLY THICK, BUT THIS SHOULD NOT HAPPEN. IT WAS DIFFICULT TO RETRIEVE THE BROKEN PIECE. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: NO INCIDENCE ON THE PATIENT STATUS, EXCEPT THE DIFFICULTY TO TAKE THE PLASTIC PIECES OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13185203 ↗
• MalfunctionOct 8, 2020Break; Break

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: [TRANSLATION] DURING THE INTRODUCTION OF THE TROCAR DURING A CHOLECYSTECTOMY, THE TROCAR SNAPPED WITH THE OBTURATOR. THE PATIENT WAS NOT INJURED BY THIS INCIDENT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 02OCT20: THE FRACTURE DID NOT CAUSE PARTICULATION. THIS PORT WAS USED AS AN ANCILLARY PORT. METHOD OF INSERTION WAS NORMAL WITH THE MOVEMENT "HORAIRE/ANTIHORAIRE" (CLOCKWISE/COUNTERCLOCKWISE) KII 5MM. INTERVENTION: THE SURGEON TOOK ANOTHER CTF12 TROCAR AFTERWARDS AND EVERYTHING WENT WELL. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648902 ↗
• MalfunctionJan 27, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDIX EVENT DESCRIPTION: DR (B)(6) WAS THE SURGEON, HE HAS USED APPLIED MEDICAL KII TROCARS MANY, MANY TIMES AT THIS HOSPITAL. INCIDENT OCCURRED DURING CEPOD LIST WITH A HIGH BMI PATIENT HAVING A LAPAROSCOPIC APPENDECTOMY. PNEUMO PERITONEUM WAS ACHIEVED VIA HASSON APPROACH WITH 12MM KII TROCAR, SECOND TROCAR WAS PLACES SUCCESSFULLY, THE PROBLEM HAPPENED ON THE 3RD TROCAR (SUPRAPUBIC) BEING PLACED UNDER DIRECT VISION. DR (B)(6) ADVISED ME THAT THE PATIENT HAD VERY TOUGH PERITONEUM, THE TROCAR IN QUESTION ESSENTIALLY BENT (DID NOT SHATTER) WHILST TRYING TO GET THE TIP THROUGH THE TOUGH PERITONEUM. ANOTHER TROCAR (IDENTICAL) WAS OPENED AND SUCCESSFULLY INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUE OR INJURY TO PATIENT. TYPE OF INTERVENTION: ANOTHER TROCAR WAS OPENED AND SUCCESSFULLY INSERTED. PATIENT STATUS: NO PATIENT ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9634974 ↗
• MalfunctionJan 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: INSTRUMENT GUIDE DROPPED INTO THE PATIENTS ABDOMEN DURING SURGERY. BY LUCK THE ASSISTANCE SURGEON SAW THIS AND WAS ABLE TO RETRIEVE THE PLASTIC INSTRUMENT GUIDE. DKMA REPORT RECEIVED VIA EMAIL ON 14JAN2020 (TRANSLATION PROVIDED BY TERRITORY MANAGER): DURING A LAPAROSCOPIC CHOLECYSTECTOMY DISCOVERED THE ASSISTING DOCTOR A PLASTIC PIECE LAYING LOOSE INSIDE THE PATIENTS ABDOMINAL CAVITY BETWEEN THE INTESTINES. THE SURGEON GETS THE PLASTIC PIECE OUT AND DISCOVER THAT IT CAME FROM THE TROCAR. IT IS A COINCIDENCE THAT PLASTIC PIECE IS FOUND DUE TO LIMITED VISION DURING A LAPAROSCOPIC SURGERY THE PLASTIC PIECE COULD HAVE DISAPPEARED BETWEEN THE INTESTINES. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624211 ↗
• MalfunctionApr 5, 2018Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: INGUINAL HERNIA. EVENT DESCRIPTION: DURING A LAPAROSCOPY (INGUINAL HERNIA), THE SURGEON NOTICED A RESISTANCE TO THE PASSAGE OF INSTRUMENTS AT THE LEVEL OF A TROCAR OF 5MM. WHEN CHECKING THE ABDOMEN BEFORE CLOSING, WE NOTICED THAT THE TROCAR VALVE HAD FALLEN INTO THE BELLY OF THE PATIENT (SEE PHOTOS ATTACHED BY MAIL) WE REMOVED THE VALVE DURING LAPAROSCOPY. THANKS TO OUR VIGILANCE NONE, BUT THE SMALL SIZE OF THE OBJECT MAKES IT NOT IMPOSSIBLE THAT WE DO NOT SEE IT IF IT RE-OCCURRED. TYPE OF INTERVENTION: WE REMOVED THE VALVE DURING LAPAROSCOPY. PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7401292 ↗
• MalfunctionAug 14, 2017Bent; Bent

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: SURGEON USING CTF12 IN LAP CHOLE. AT START OF PROCEDURE DURING TROCAR INSERTION, THE TROCAR BENT. THE TROCAR DID NOT PENETRATE THROUGH THE PERITONEUM. TROCARS WERE REPLACED WITH ANOTHER PACK OF CTF12 AND CASE COMPLETED. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6793142 ↗
• MalfunctionMar 22, 2017Bent; Bent

  PROCEDURE PERFORMED UNKNOWN - "TROCAR BENT DURING PLACEMENT ON THE PATIENT." PATIENT STATUS: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425905 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  APPENDECTOMY- "DURING AN APPENDECTOMY UNDER LAPAROSCOPY THE SURGEON INTRODUCED SCISSORS IN THE 5MM TROCAR. A PIECE OF BLACK RUBBER FELL THEN INTO THE BELLY OF THE PATIENT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372903 ↗
• MalfunctionMar 2, 2017Fracture; Fracture

  PROCEDURE PERFORMED: LAPARASCOPY. "SURGEON: DR (B)(6), SCRUB: (B)(6). DUAL PACK CTF12 OPENED. FIRST TROCAR ENTRY NOTICED BY SURGEON TO BE "MORE DIFFICULT TO INSERT DUE TO INCREASE RESISTANCE". TROCAR PLACED. CONTINUED TO ADVANCE PORT WITH 10-2 ROTATION AND BENT TROCAR WITH OBTURATOR ON ENTRY. SEQUENTIAL HELIX TO BE INVESTIGATED. PORT REMOVED. NEW TROCAR CFF03 HANDED OFF TO SURGEON AND INSERTED IN TO THE SAME INCISION, SAME LOCATION WITH NO ISSUE." PATIENT STATUS: NIL ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372201 ↗
• MalfunctionApr 13, 2016Break; Break

  LAP CHOLE - "SURGEON WAS USING DIRECT VISION TO GAIN ACCESS/PLACE ONE OF THE PORTS AND THE TIP BROKE OFF OF THE OBTURATOR DURING THIS ACTION." TYPE OF INTERVENTION: "THE BROKEN TIP WAS FOUND AND RECOVERED." PATIENT STATUS - "THEY DIDN'T EXPRESS FURTHER CONCERN AFTER THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5575032 ↗