Kii Fios Dual Pack CFF12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915124090), received between Nov 14, 2017 and Jun 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• MalfunctionJun 26, 2026Fracture

  PROCEDURE PERFORMED: NOT KNOWN. EVENT DESCRIPTION: [TRANSLATION] THE TROCAR BROKE WHEN IT WAS REMOVED FROM ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REP VIA EMAIL ON 19-JUN-2026: NO PATIENT OR USER INJURY AS A RESULT OF THIS EVENT. THE EVENT OCCURRED UPON REMOVAL FROM PACKAGING. THE BREAKAGE OCCURRED ON THE STEM. IT WAS A CLEAN BREAKAGE. THE BREAKAGE DIDN'T RESULT IN THE FORMATION OF PARTICLES. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REP VIA EMAIL ON 23JUN26: THE BREAK OCCURRED IN THE CANNULA. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REP VIA EMAIL ON 24-JUN-2026: MY INTERLOCUTOR TELLS ME THE CANNULA WAS ALSO BROKEN. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637554 ↗
• MalfunctionFeb 10, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC SURGICAL PROCEDURE. EVENT DESCRIPTION: COMPLAINT ALONG WITH SWISSMEDIC USER REPORT FORM WAS RECEIVED FROM CUSTOMER VIA AN APPLIED MEDICAL REP VIA EMAIL ON 22JAN2026. SAME INFORMATION WAS RECEIVED BY PCF VIA AN APPLIED MEDICAL REP VIA EMAIL ON 22JAN2026 WITH TRANSLATION: SEVERAL PLASTIC PARTICLES WERE DETECTED IN THE SURGICAL SITE. THE PARTICLES CLEARLY ORIGINATED FROM THE TROCAR USED AND HAD NOT BEEN PRESENT IN THE OPERATIVE AREA BEFOREHAND. AFTER THE INCIDENT WAS IDENTIFIED, THE SURGICAL PROCEDURE WAS INTERRUPTED TO ALLOW FOR A THOROUGH INSPECTION OF THE SITE. DUE TO THE NECESSARY ADDITIONAL MEASURES, THERE WAS A DELAY IN THE SURGICAL PROCEDURE. AS A RESULT OF THE PROLONGED DURATION OF THE OPERATION, AN EXTENDED ANESTHESIA TIME WAS REQUIRED. HAD THE PLASTIC PARTICLES REMAINED UNDISCOVERED IN THE SURGICAL SITE, THE FOLLOWING POTENTIAL RISKS COULD HAVE OCCURRED: FOREIGN BODY REACTIONS, INFLAMMATORY PROCESSES OR INFECTIONS, ABSCESS FORMATION. THE SURGICAL PROCEDURE WAS INTERRUPTED TO ALLOW FOR A THOROUGH INSPECTION OF THE SITE AND ALL VISIBLE PLASTIC PARTICLES WERE COMPLETELY REMOVED FROM THE SURGICAL AREA. LONGER OPERATION MEANT EXTENDED ANESTHESIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309885 ↗
• MalfunctionApr 22, 2022Break; Material Fragmentation; Break; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: TRANSLATION: THE OPERATING ROOM HAD A PROBLEM YESTERDAY WITH A BROKEN OBTURATOR TIP ON REFERENCE CFF12 LOT 1428854. NO PATIENT INCIDENCE, THE MATERIAL HAS BEEN CHANGED. IT IS AVAILABLE FOR RETURN, FOR EXPERTISE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 14 APR 2022: DR. INTRODUCED HIS TROCAR AND ON CONTACT WITH THE TISSUES THE END OF IT BROKE. HE CHANGED HIS TROCAR AND WAS ABLE TO OPERATE ON HIS PATIENT WITHOUT ANY PROBLEM. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190915 ↗
• MalfunctionMar 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP ENDOMETRIOSIS. EVENT DESCRIPTION: SPOT COAGULATION WITH SHARP TIPPED [] BIPOLAIR ELECTRODE. SEAL PROTECTION WAS PUNCTURED AND ENDED UP IN THE PATIENTS ABDOMEN. WAS ALSO REMOVED AFTER DISCOVERY. PUNCTURE OF THE SEAL PROTECTION WAS CONCLUDED POST PROCEDURE WHEN SEAL HOUSING WAS TAKEN APART TO INVESTIGATE. ADDITIONAL INFORMATION RECEIVED FROM TEAM MEMBER BY EMAIL ON 06MAR2020: IT WAS THE ENTIRE INSTRUMENT SHIELD THAT SEPARATED FROM THE SEAL HOUSING. INTERVENTION: RETRIEVAL OF SEPARATED PART. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829989 ↗
• MalfunctionFeb 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY. EVENT DESCRIPTION: TOWARDS THE END OF THE CASE, WHEN THE SURGEON INSERTED THE SCOPE TO DO THE FINAL CHECK, HE NOTICED THE INSTRUMENT SHIELD FROM THE TROCAR WAS INSIDE THE PATIENT. HE HAS RETRIEVED IT. THE NURSE DID NOTE, THERE WAS AN ASPIRATION NEEDLE USED FOR THE GALL BLADDER AND INITIALLY IT DIDN'T GO THROUGH INITIALLY ON THE FIRST ATTEMPT. THEY STATED IT COULD BE DUE TO THE NEEDLE BUT NEVER HAD THIS EXPERIENCE BEFORE. HAVE ISOLATED FOR RETURN ALONG WITH OTHER TROCARS WITH THE SAME LOT NUMBER. ADDITIONAL INFORMATION RECEIVED VIA ADVERSE INCIDENT REPORT, 7TH FEBRUARY 2019: INTERNAL VALVE DETACHED FROM BLACK BUNG INSIDE THE SLEEVE OF PORT AND WAS FOUND IN ABDOMINAL CAVITY. THE ONLY INSTRUMENTS INTRODUCED INTO THE PORT WERE A LAPAROSCOPIC TISSUE FORCEP AND A ASPIRATION NEEDLE. THERE WAS A LITTLE RESISTANCE WHEN TRYING TO INTRODUCE THE ASPIRATION NEEDLE WHICH IS THE ONLY ANOMALY DURING A ROUTINE PROCEDURE. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): INTERNAL VALVE REMOVED FROM PATIENT AND PORT KEPT FOR ANALYSIS. EXAMINATION AND COMPARISON OF THE SAME 5 MM PORT TO ENSURE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376352 ↗
• MalfunctionNov 14, 2017Physical Resistance; Physical Resistance

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER SATISFACTION ON (B)(6) 2017: BY (B)(6) THE HOSPITAL MEANS THAT THE SLEEVE OF THE TROCAR WAS LIKE JAMMED. THE SLEEVE DID NOT ALLOW INSTRUMENTS TO EASILY SLIDE INSIDE IT. REGARDING THE QUESTION RELATED TO THE INSTRUMENTS NOT STOPPING A CERTAIN DEPTH INTO THE TROCAR, THIS WAS A QUESTION ASKED BY RA TEAM IN THE US. THE RESPONSE PROVIDED BY THE SALES REP CONFIRMED THAT THE INSTRUMENTS WERE SLIDING INSIDE THE SLEEVE WITH DIFFICULTY BUT WITHOUT BEING STOPPED AT ANY POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7031242 ↗