Kii Fios Dual Pack CFF14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915124618), received between Jul 16, 2018 and Jan 27, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GYN. PROCEDURE. EVENT DESCRIPTION: 5 MM ADVANCED FIXATION TROCAR, CFF05. THE TIP IS BROKEN AND IT HAPPENED WHEN INSERTION OF THE TROCARS. GYN. PROCEDURE. LOT: 1507555. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20JAN25: IT WAS CONFIRMED THE DEVICE IS CFF14 LOT 1507555. THE TM BECAME AWARE ON 13JAN25. THE PRODUCT IS NOT RETURNING BUT WOULD LIKE A REPLACEMENT. CURRENTLY UN AWARE OF EVENT DATE. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 22JAN25: TM CONFIRMED IT WAS THE OBTURATOR TIP THAT WAS BROKEN THAT DID NOT CAUSE PARTICULATION AND THE OBTURATOR WAS IN THE CANNULA AT THE TIME OF THE INCIDENT. IT IS NOT KNOWN REGARDING THE TECHNIQUE OF INSERTION; THE RESPONSIBLE NURSE WAS NOT IN THE ROOM. THE TROCAR AS NOT USED ROBOTICALLY. PATIENT STATUS: THE PATIENT WAS NOT INJURED IN THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246870 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL SALPINGO OOPHORECTOMY. EVENT DESCRIPTION: IT WAS REPORTED VIA EMAIL THAT DURING A LAPAROSCOPIC BSO ON (B)(6) 2024, THAT UPON FINAL INSPECTION OF THE PROCEDURE, A SMALL PIECE OF PLASTIC WAS IDENTIFIED AND RETRIEVED FROM THE PATIENTS ABDOMEN. THERE WERE NO VISIBLE SIGNS OF DAMAGE OF THE PRODUCTS USED, AND THE THEATRE MANAGER KEPT THE TROCARS AND THE PIECE OF PLASTIC FOR INSPECTION. APPLIED MEDICAL REPRESENTATIVE INSPECTED THE PRODUCTS AND IT APPEARS THAT THE INSTRUMENT GUARD HAD DETACHED FROM THE SEAL HOUSING DURING THE PROCEDURE. NO SWABS WERE PUT THROUGH THE PORTS. THE GRASPER USED WAS A [BRAND NAME] OFF OUR LAPAROSCOPIC SET A [BRAND NAME] LAPAROSCOPIC GRASPER SHORT. WE ALSO USED AN ASPIRATING NEEDLE DOWN THE 5MM BALLOON PORT TO DRAW FLUID OUT OF THE OVARIAN CYST ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 12AUG24 BY APPLIED MEDICAL REPRESENTATIVE: PATIENT IS OK AFTER THIS EVENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. TYPE OF INTERVENTION: THE OPERATING SURGEONS IDENTIFIED THE PIECE OF PLASTIC AND IT WAS RETRIEVED. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043390 ↗
• MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC EXCISION OF ENDOMETRIOSIS. EVENT DESCRIPTION: COMPLAINT PRODUCT FAMILY: TROCAR, PRODUCT NAME: KII FIOS 5X75MM AF DUAL PACK, MODEL NUMBER: CFF14, LOT NUMBER: UNKNOWN. IT IS UNKNOWN IF THE EVENT HAS OCCURRED BEFORE USE, DURING TREATMENT OR POST-TREATMENT OF AN UNKNOWN PROCEDURE. IT IS UNKNOWN WHAT ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED. OBTURATOR WAS BENDY AND DID NOT GO DOWN SLEEVE WITHOUT FORCE. WHEN ABLE TO BE INSERTED INTO SLEEVE, FRAGMENTS OF PLASTIC WENT EVERYWHERE. IT IS UNKNOWN IF THERE WAS ANY CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. IT IS UNKNOWN HOW THE USER RESOLVED THE SITUATION AND WHAT OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. IT IS UNKNOWN IF THERE WAS A PATIENT INJURY OR ILLNESS ASSOCIATED WITH THE COMPLAINT EVENT. THE PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM TERRITORY MANAGER VIA EMAIL ON 19-MAR-2024: MODEL NUMBER WAS CONFIRMED AS CFF14 AND LOT NUMBER AS 1485863. IT WAS JUST THE ONE DUAL PACK IMPACTED DURING USE OF LAPAROSCOPIC EXCISION OF ENDOMETRIOSIS PROCEDURE. WHILE INTRODUCING THE PORT INTO THE ABDOMEN, THE TIP WAS FOUND TO BE BENT DURING USE AND ON AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000234 ↗
• MalfunctionJul 8, 2020Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: IN A [AGE] YEAR-OLD PATIENT TREATED FOR ADNEXAL TORSION, WHEN THE TROCAR IS USED, THE TIP IS BENT ALLOWING NOT ITS INTRODUCTION AFTER INCISION. CLINICAL CONSEQUENCES: CHANGE OF INTRODUCER. NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM THE CUSTOMER ON (B)(6)2020 : THE OPERATION WAS AN ADNEXAL TORSION SUPPORT, THE INCIDENT WAS IDENTIFIED WHEN TRYING TO USE THE DEVICE FOR INSERTION. THE OBTURATOR WAS WELL IN THE CANULA AT THE TIME OF USE. NORMAL USE OF THE DEVICE HAS BEEN DESCRIBED WITHOUT THE APPLICATION OF EXCESSIVE FORCE. INTERVENTION: CHANGE OF INTRODUCER PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10246623 ↗
• MalfunctionJul 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP BY EMAIL ON (B)(6) 2018:THE SHIELD HAS BEEN DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692315 ↗