Kii Fios Dual PackRecalls & reported problems across all models

We found 5 models of Kii Fios Dual Pack by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2016 and Aug 11, 2026 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Kii Fios Dual Pack problems

Kii Fios Dual Pack models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Kii Fios Dual Pack CTF12

  Laparoscope, General & Plastic Surgery
  16 reports
• Kii Fios Dual Pack CFF12

  Laparoscope, General & Plastic Surgery
  6 reports
• Kii® Fios® Dual Pack CTF75

  Laparoscope, General & Plastic Surgery
  6 reports
• Kii Fios Dual Pack CFF14

  Laparoscope, General & Plastic Surgery
  5 reports
• Kii Fios Dual Pack CTF35

  Laparoscope, General & Plastic Surgery
  2 reports

Recent Kii Fios Dual Pack adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 8, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP HYSTERECTOMY . EVENT DESCRIPTION: TRANSLATION DURING SURGERY AT 8/12, A TROCAR 11X100 KII FIOS DUAL PACK FROM APPLIED (REF: CTF35) WAS NOTED TO HAVE A DEFECT. THE TIP OF THE TROCAR PIN HAS AN ABNORMAL SHAPE, SO IT COULD NOT BE USED IN THE PROCEDURE. THE TIP OF THE PIN APPEARS "MELTED" INTERVENTION: ANOTHER TROCAR. PATIENT STATUS: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330402 ↗
• 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 ↗
• 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 ↗

Other Applied Medical Resources Corporation products

• Inzii Retrieval System3 models · 796 reports
• Kii Fios First Entry18 models · 587 reports
• Kii Optical Access System18 models · 309 reports
• Kii Balloon Blunt Tip System3 models · 263 reports
• VOYANT 5mm Fusion Device4 models · 257 reports
• Epix Laparoscopic Scissors2 models · 245 reports
• VOYANT Maryland Fusion Device5 models · 132 reports
• Kii Sleeve7 models · 130 reports