Kii® Fios® Dual Pack CTF75Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915129903), received between Sep 8, 2017 and Jan 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Physical Resistance/Sticking

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION: OPTICS DAMAGED DUE TO REGULAR FRICTION DURING PASSAGE THROUGH. WAITING FOR FURTHER DETAILS. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20NOV2025: THE SURGEON ENCOUNTERED RESISTANCE WHEN INSERTING THE OPTICAL TROCAR, WHICH CAUSED IT TO RUB. WHEN THE SURGICAL ASSISTANT MANIPULATES THE TROCAR, SHE HAS TO HOLD IT IN PLACE, OTHERWISE IT SLIPS OUT OF THE ABDOMINAL CAVITY. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE PROBLEM IS RECURRING. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 21NOV2025: WHEN THE SURGEON FELT THE RESISTANCE, DID HE CONTINUE TO USE THAT TROCAR OR DID HE CHANGE TO A NEW TROCAR? CONTINUE TO USE THAT TROCAR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 25NOV2025: EVERY TIME THIS TROCAR IS USED, THE ASSISTANT SYSTEMATICALLY HOLDS THE TROCAR TO PREVENT IT FROM COMING OUT OF THE ABDOMINAL CAVITY. I DON'T THINK THEY REPORT IT TO US EVERY TIME. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 18DEC2025: RESISTANCE WAS FELT WHEN THE OBTURATOR WAS INSERTED (NOT DURING INSTRUMENT EXCHANGE). OPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038343 ↗
• MalfunctionJan 9, 2026Physical Resistance/Sticking

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION: OPTICS DAMAGED DUE TO REGULAR FRICTION DURING PASSAGE THROUGH. WAITING FOR FURTHER DETAILS. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20NOV2025: THE SURGEON ENCOUNTERED RESISTANCE WHEN INSERTING THE OPTICAL TROCAR, WHICH CAUSED IT TO RUB. WHEN THE SURGICAL ASSISTANT MANIPULATES THE TROCAR, SHE HAS TO HOLD IT IN PLACE, OTHERWISE IT SLIPS OUT OF THE ABDOMINAL CAVITY. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE PROBLEM IS RECURRING. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 21NOV2025: WHEN THE SURGEON FELT THE RESISTANCE, DID HE CONTINUE TO USE THAT TROCAR OR DID HE CHANGE TO A NEW TROCAR? CONTINUE TO USE THAT TROCAR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 25NOV2025: EVERY TIME THIS TROCAR IS USED, THE ASSISTANT SYSTEMATICALLY HOLDS THE TROCAR TO PREVENT IT FROM COMING OUT OF THE ABDOMINAL CAVITY. I DON'T THINK THEY REPORT IT TO US EVERY TIME. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE ON 18DEC2025: RESISTANCE WAS FELT WHEN THE OBTURATOR WAS INSERTED (NOT DURING INSTRUMENT EXCHANGE). OPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028688 ↗
• MalfunctionJul 14, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION: [TRANSLATION] INTRODUCTION OF THE TROCAR PER OP, WHEN THE CAMERA IS INSERTED, THE TROCAR VALVE FALLS INTO THE PATIENT'S BELLY, THUS DETACHING ITSELF FROM THE STEM. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09JUL25: THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE, EVENT DATE 30JUN25 WITH PROCEDURE PERFORMED WAS SLEEVE GASTRECTOMY AND CONCOMITANT DEVICES USED DURING ARE TROCAR 5MM AND GRASPER. ALL BLACK IN COLOUR PIECES WERE RETRIEVED FROM THE PATIENT AND IT WAS CONFIRMED THE ENTIRE COMPONENT FELL OUT. BEFORE AND T THE TIME OF THE INCIDENT A FENESTRATED CLAMP. THE INTERNAL SEAL COMPONENTS WAS REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. NO IMAGES/VIDEO AVAILABLE. DEVICE IS AVAILABLE FOR RETURN. INTERVENTION: VALVE RETRIEVED FROM THE BELLY - CHANGE OF TROCAR. PATIENT STATUS: THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494640 ↗
• MalfunctionFeb 4, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CONVERSION OF GASTRIC SLEEVE TO ROUX-EN-Y BYPASS. EVENT DESCRIPTION: THIS INFORMATION CAME DIRECTLY FROM THE SURGEON. TOWARDS THE END OF THE OPERATION, HE NOTICED BY THE CHANCE THAT A PART OF THE TROCAR SLEEVE HAD BROKEN OFF WHILE THE FOOT POINT ANASTOMOSIS WAS BEING MADE. THIS PART WAS THEN SEARCHED AND AFTER 15 MIN IT WAS FOUND. HIS PERSONAL ASSUMPTION: HE CONSIDERS A MATERIAL DEFECT TO BE UNLIKELY. RETROSPECTIVELY THIS PIECE MOST LIKELY BROKE OFF DURING THE PRODUCTION OF THE FOOT PRINT ANASTOMOSIS, WHERE THE [COMPETITOR STAPLING DEVICE] HAS TO BE ANGLED TO THE MAXIMUM. IT SEEMS MOST LIKELY TO HIM THAT DURING THIS TIME, POSSIBLY WHEN THE JOINT OF THE [COMPETITOR STAPLING DEVICE] WAS NOT FULLY INSERTED, THE SAID PIECE BROKE OUT DUE THE ANGULATION IN THE TROCAR SLEEVE. AFTER THEY FOUND THE PIECE THE SURGERY COULD FINISHED WITHOUT ANY PROBLEMS. FROM CUSTOMER NOTIFICATION, TRANSLATION: A PIECE OF THE END OF THE SLEEVE OF ABOUT 1CM SQUARE IN SIZE FELL INTO THE ABDOMEN. THERE WAS NO HARM TO THE PATIENT, THE FRAGMENT COULD BE FOUND AFTER A 15-MINUTE SEARCH. IT WAS THE OPTICAL FIRST ACCESS PORT IN THE LEFT UPPER ABDOMEN, ABOUT 3 FINGERS' WIDTH UNDER THE LEFT COSTAL A

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11283261 ↗
• MalfunctionFeb 28, 2020Break; Break

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: TRANSLATION AME: DURING THE OPERATION, THE TROCAR BROKE IN TWO. PART OF IT REMAINED IN THE PATIENT, AND WAS VERY DIFFICULT TO RECOVER. INFORMATION FROM THE CRO: "PLACEMENT OF TWO 10MM TROCARS IN RIGHT HYPOCHONDRIUM AND IN THE UMBILICUS. PLACEMENT OF A 5MM TROCAR IN THE RIGHT SUBCOSTAL AREA. PLACEMENT OF A [BRAND NAME] RETRACTOR. THE LEFT PEDICLE IS INITIALLY FREED. GASTROLYSIS IS PERFORMED WITH THE HELP OF THE ULTRACISION. THE UMBILICAL TROCAR FRAGMENTS INTO 2 PIECES. THESE ARE REMOVED VIA THE LEFT HYPOCHONDRIUM TROCAR." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 18FEB2020: THERE WERE MORE THAN THREE TROCARS, FIVE IN ALL I'D SAY. SO THERE WAS ONE IN THE LEFT HYPOCHONDRIUM. I DON'T REMEMBER EXACTLY WHICH DM WAS IN PLACE IN THE TROCAR THAT BROKE, BUT IT WAS EITHER THE ULTRACUTTER OR A LAPAROSCOPIC GRASPING FORCEPS AS IT WAS BEFORE THE STAPLING. INTERVENTION: REMOVAL OF SEPARATED PIECE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771228 ↗
• MalfunctionSep 8, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: EQUIPMENT USED - [COMPETITOR] CLIP APPLIER, REUSABLE GRASPERS, DISPOSABLE SCISSORS. AS MR [NAME] COMPLETED HIS LAPAROSCOPIC PROCEDURE HE NOTICED A PIECE OF BLACK MATERIAL INSIDE THE PATIENT. HE SUBSEQUENTLY REMOVED THIS ITEM AND NOTICED THIS WAS A PIECE OF BLACK RUBBER. HE THEREFORE INSPECTED THE PORTS AND DISCOVERED THAT ONE OF THE CTF75 PORTS SHOWED A CORRESPONDING PIECE MISSING FROM THE INNER DOUBLE DUCK BILL SEAL. THIS WAS REPORTED TO MYSELF AND THE PATIENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT RECOVERED AS EXPECTED. 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 6854090 ↗