Kii Fios First Entry CTF74Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607915123710), received between Oct 19, 2016 and Apr 22, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ADRENALECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4), COMPLAINT 2 OF 3: (B)(4), COMPLAINT 3 OF 3: (B)(4). CTF74 WAS BEING USED A S A FIRST ENTRY PORT, THE PATIENT WAS LAY IN A LATERAL POSITION AND THE PORT WAS BEING PLACED ABOVE THE RIGHT KIDNEY. THEY FEEL THE WEIGHT AND THE PRESSURE OF THE PATIENT MAY HAVE BEEN A FACTOR IN BREAKING THE TROCAR. THEY REPLACED THE PORT WITH THE SAME PORT AND THE CANULA SNAPPED IN THE SAME PLACE. HAVING TO USE 3 REPLACEMENT PORTS. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11APR25: TM FOLLOWED UP WITH THE CUSTOMER TO CLARIFY AND AS STATED BY THE SURGEON: "WE HAVE CONCERNS ABOUT USING APPLIED MEDICAL TROCARS, HAVING HAD 3 SNAP IN THE LAST 2 PATIENTS THAT WE USED THEM IN. BOTH CASES HAVE BEEN POSTERIOR LAPAROSCOPIC ADRENALECTOMIES, WHERE THE PATIENT IS IN A PRONE KNEELING POSITION AND THE PORTS ARE INSERTED UNDER THE 12TH RIB IN THE BACK. THE FIRST PORT WAS IN A BIG MAN, AND WE QUERIED INITIALLY WHETHER THIS WAS DUE TO DIFFICULT ACCESS AND PRESSURE. THE SECOND REPLACEMENT PORT (IN THE SAME PATIENT) SNAPPED AFTER INSERTION WITH MINIMAL PRESSURE. THE THIRD PORT WAS IN AN EXTREMELY THIN LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884628 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ADRENALECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4). COMPLAINT 2 OF 3: (B)(4). COMPLAINT 3 OF 3: (B)(4). CTF74 WAS BEING USED A S A FIRST ENTRY PORT, THE PATIENT WAS LAY IN A LATERAL POSITION AND THE PORT WAS BEING PLACED ABOVE THE RIGHT KIDNEY. THEY FEEL THE WEIGHT AND THE PRESSURE OF THE PATIENT MAY HAVE BEEN A FACTOR IN BREAKING THE TROCAR. THEY REPLACED THE PORT WITH THE SAME PORT AND THE CANULA SNAPPED IN THE SAME PLACE. HAVING TO USE 3 REPLACEMENT PORTS. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11APR25: TM FOLLOWED UP WITH THE CUSTOMER TO CLARIFY AND AS STATED BY THE SURGEON: "WE HAVE CONCERNS ABOUT USING APPLIED MEDICAL TROCARS, HAVING HAD 3 SNAP IN THE LAST 2 PATIENTS THAT WE USED THEM IN. BOTH CASES HAVE BEEN POSTERIOR LAPAROSCOPIC ADRENALECTOMIES, WHERE THE PATIENT IS IN A PRONE KNEELING POSITION AND THE PORTS ARE INSERTED UNDER THE 12TH RIB IN THE BACK. THE FIRST PORT WAS IN A BIG MAN, AND WE QUERIED INITIALLY WHETHER THIS WAS DUE TO DIFFICULT ACCESS AND PRESSURE. THE SECOND REPLACEMENT PORT (IN THE SAME PATIENT) SNAPPED AFTER INSERTION WITH MINIMAL PRESSURE. THE THIRD PORT WAS IN AN EXTREMELY THIN LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876320 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ADRENALECTOMY: EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4). COMPLAINT 2 OF 3: (B)(4). COMPLAINT 3 OF 3: (B)(4). CTF74 WAS BEING USED A S A FIRST ENTRY PORT, THE PATIENT WAS LAY IN A LATERAL POSITION AND THE PORT WAS BEING PLACED ABOVE THE RIGHT KIDNEY. THEY FEEL THE WEIGHT AND THE PRESSURE OF THE PATIENT MAY HAVE BEEN A FACTOR IN BREAKING THE TROCAR. THEY REPLACED THE PORT WITH THE SAME PORT AND THE CANULA SNAPPED IN THE SAME PLACE. HAVING TO USE 3 REPLACEMENT PORTS. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11APR25: TM FOLLOWED UP WITH THE CUSTOMER TO CLARIFY AND AS STATED BY THE SURGEON: "WE HAVE CONCERNS ABOUT USING APPLIED MEDICAL TROCARS, HAVING HAD 3 SNAP IN THE LAST 2 PATIENTS THAT WE USED THEM IN. BOTH CASES HAVE BEEN POSTERIOR LAPAROSCOPIC ADRENALECTOMIES, WHERE THE PATIENT IS IN A PRONE KNEELING POSITION AND THE PORTS ARE INSERTED UNDER THE 12TH RIB IN THE BACK. THE FIRST PORT WAS IN A BIG MAN, AND WE QUERIED INITIALLY WHETHER THIS WAS DUE TO DIFFICULT ACCESS AND PRESSURE. THE SECOND REPLACEMENT PORT (IN THE SAME PATIENT) SNAPPED AFTER INSERTION WITH MINIMAL PRESSURE. THE THIRD PORT WAS IN AN EXTREMELY THIN LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876103 ↗
• MalfunctionNov 17, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION]. DIFFICULTIES INSERTING THE LAPARO TROCAR INTO THE ABDOMEN BECAUSE THE TIP OF THE OBTURATOR IS NOT COMPLIANT (CURVED). IMPOSSIBLE TO ACCESS THE ABDOMINAL WALL. CHANGE OF TROCAR. INTERVENTION: CHANGE OF TROCAR. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818755 ↗
• MalfunctionOct 20, 2021Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC ADRENALECTOMY. EVENT DESCRIPTION: PRODUCT SNAPPED INTO TWO PIECES, LEAVING ONE PIECE IN THE PATIENT WHERE THEY THEN HAD TO WIDEN THE INCISION TO REMOVE FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY HOSPITAL VIA EMAIL 15OCT21: THERE WAS NO INJURY TO THE PATIENT. IT HAPPENED AT THE BEGINNING OF THE PROCEDURE. I STILL HAVE THE PORT. ADDITIONAL INFORMATION PROVIDED BY HOSPITAL VIA EMAIL 18OCT21: IT HAPPENED NEAR THE START OF THE PROCEDURE, WHICH WAS A POSTERIOR LAPAROSCOPIC ADRENALECTOMY. THE PATIENT IS PLACED IN A PRONE JACK-KNIFE POSITION AND 3 PORTS ARE INSERTED THROUGH THE BACK. IT WAS THE MEDIAL PORT THAT SNAPPED, THIS WAS PLACED VIA PALPATION AND WE HAVE NEVER HAD THIS PROBLEM BEFORE. AS IT WAS IN THE RETROPERITONEAL SPACE IT WAS DIFFICULT TO RETRIEVE THE SNAPPED END AS THERE ISN'T A LARGE SPACE TO FIND IT SO WAS TECHNICALLY CHALLENGING. INTERVENTION: COMPONENT REMOVED. PATIENT STATUS: NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665933 ↗
• MalfunctionMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: (TRANSLATION): THE TROCAR SEAL DISLODGED IN THE PATIENT'S ABDOMEN. NO CLINICAL CONSEQUENCES. RECOVERY OF THE SEAL IN THE PATIENT'S ABDOMEN. REMOVAL OF THE DEVICE. USE OF A NEW TROCAR. INTERVENTION: COMPONENT REMOVED, CHANGE OF DEVICE. PATIENT STATUS: NO CLINICAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777259 ↗
• MalfunctionNov 16, 2016Break; Break

  REPORT FROM SALES REPRESENTATIVE (WHO WAS NOT PRESENT AT THE CASE): UNKNOWN PROCEDURE - (QUOTING THE DOCTOR DAY AFTER EVENT) "THE PATIENT WAS YOUNG SLENDER MALE. VERY TIGHT ABDOMEN. I DIDN'T MAKE MY INCISION LARGE ENOUGH. I WENT IN AT ANGLE. I REMOVED THE TROCAR AND NOTICED THE TIP WAS BENT, NOT BROKEN. I TRIED TO SEE IF IT WOULD STRAIGHTEN OUT WITH MY FINGERS. IT BROKE OFF AT THAT TIME." PRODUCT WAS CTF74. NO PATIENT INJURY. USED ANOTHER CTF 74 THAT WORKED FINE AFTER ENLARGING THE ENTRY SITE. SITE WAS LEFT LOWER QUADRANT APPROX. 3 TO 4 INCHES FROM UMBILICUS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON NOVEMBER 7, 2016: IT WAS JUST THE OBTURATOR TIP THAT BENT. NOT THE CANNULA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108137 ↗
• MalfunctionOct 19, 2016Material Fragmentation; Material Fragmentation

  "DOCTOR (B)(6) WAS DOING A LAP TUBAL AND PART OF THE RUBBER AIR SEAL BROKE OFF. SHE NOTICED IT IMMEDIATELY AND WAS ABLE TO EASILY REMOVE IT FROM THE PATIENT." "NO HARM WAS DONE TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6042577 ↗