Kii Fios First EntryRecalls & reported problems across all models

We found 18 models of Kii Fios First Entry by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 587 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2016 and Sep 29, 2026 — classified as 1 death, 9 injuries, 577 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (244 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 First Entry problems

Kii Fios First Entry models

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

• Kii Fios First Entry CTF73

  Laparoscope, General & Plastic Surgery
  157 reports
• Kii Fios First Entry CTF03

  Laparoscope, General & Plastic Surgery
  77 reports
• Kii Fios First Entry CFF73

  Laparoscope, General & Plastic Surgery
  65 reports
• Kii Fios First Entry CFF33

  Laparoscope, General & Plastic Surgery
  64 reports
• Kii Fios First Entry CTF33

  Laparoscope, General & Plastic Surgery
  1 death61 reports
• Kii Fios First Entry CTF71

  Laparoscope, General & Plastic Surgery
  53 reports
• Kii Fios First Entry CFF03

  Laparoscope, General & Plastic Surgery
  33 reports
• Kii Fios First Entry CTF01

  Laparoscope, General & Plastic Surgery
  24 reports
• Kii Fios First Entry CFF71

  Laparoscope, General & Plastic Surgery
  18 reports
• Kii Fios First Entry CFF75

  Laparoscope, General & Plastic Surgery
  10 reports
• Kii Fios First Entry CTF74

  Laparoscope, General & Plastic Surgery
  8 reports
• Kii Fios First Entry CFF05

  Laparoscope, General & Plastic Surgery
  7 reports
• Kii Fios First Entry CFF01

  Laparoscope, General & Plastic Surgery
  3 reports
• Kii Fios First Entry CTF34

  Laparoscope, General & Plastic Surgery
  3 reports
• Kii Fios First Entry CFF74

  Laparoscope, General & Plastic Surgery
  1 report
• Kii Fios First Entry CFF31

  Laparoscope, General & Plastic Surgery
  1 report
• Kii Fios First Entry CTF04

  Laparoscope, General & Plastic Surgery
  1 report
• Kii Fios First Entry CTF31

  Laparoscope, General & Plastic Surgery
  1 report

Recent Kii Fios First Entry adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941295 ↗
• MalfunctionSep 11, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741735 ↗
• MalfunctionAug 19, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334140 ↗
• MalfunctionAug 11, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212726 ↗
• MalfunctionJun 23, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC GALLBLADDER OPERATION. EVENT DESCRIPTION: [TRANSLATION] DURING A LAPAROSCOPIC GALLBLADDER OPERATION, A PART HAD COME LOOSE FROM THE TROCAR THAT SHOULD HAVE BEEN FIRMLY ATTACHED TO THE INSTRUMENT. THE ISSUE WAS NOTICED WHEN THE CO2 GAS DID NOT REMAIN IN THE ABDOMINAL CAVITY, AND AN INVESTIGATION INTO THE CAUSE WAS INITIATED. THE SURGEON NOTICED A BRIGHT PLASTIC PART THAT HAD COME LOOSE FROM THE TROCAR AND A SMALL BLACK PLASTIC FRAGMENT IN THE ABDOMINAL CAVITY. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12JUN26: THE USER RESOLVED THE SITUATION BY REPLACING WITH A NEW EQUIVALENT PRODUCT. INSTRUMENTATION USED AT THE TIME OF THE INCIDENT OR PRIOR TO THE INCIDENT NOT KNOWN. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. NOT KNOWN IF THE TRANSPARENT COMPONENT FELT ENTIRE OR PARTICULATE, BUT THE DEVICE WILL RETURN FOR EVALUATION. ALL THE PIECES REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15JUN26: BELOW IS A COMPLAINT REGARDING PRODUCT REF CFF73. THE PRODUCT CAN BE PICKED UP FROM THE CUSTOMER; DETAILS ARE PROVIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602548 ↗
• MalfunctionJun 17, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC RADICAL PROSTATECTOMY. EVENT DESCRIPTION: INFORMATION RECEIVED IN THE CUSTOMER COMPLAINT FORM: THE INCIDENT INVOLVED: THE DEPARTMENT REALIZED THAT A PIECE OF PLASTIC MISSING FROM THE TIP OF THE TROCAR WHEN THE PATIENT WAS DISCHARGED. CONSEQUENCES FOR THE PATIENT: THE PIECE OF PLASTIC WAS FOUND IN THE AND WAS REMOVED. THE SYSTEM HAS BEEN RETAINED. THIS IS AN ISOLATED INCIDENT. ADDITIONAL INFORMATION RECEIVED IN THE PCF: AT THE END OF THE INTERVENTION, THEY NOTICE THAT A LITTLE PIECE OF PLASTIC BROKE AT THE TIP AND THEY FIND IT IN THE ABDOMEN OF THE PATIENT. THEY REMOVE IT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10JUN26: NO CONSEQUENCE FOR THE PATIENT. THE SURGEON FOUND AND RECOVERED THE PIECE LEFT IN THE PATIENT. IT HAPPENED AT THE END, WHEN THE TROCAR IS REMOVED. THE BREAK OCCURRED AT THE CANNULA TIP. THE BREAK CAUSED PARTICULATION AND ALL PIECES REMOVED FROM THE PATIENT. THE BREAK WAS IDENTIFIED DURING THE PATIENT¿S REMOVAL. TROCAR WAS INSERTED BY ROTATING ALTERNATELY CLOCKWISE AND COUNTERCLOCKWISE. NO DIFFICULTY DURING INSERTION AND THIS TROCAR WAS USED WITH A ROBOT. IT WAS USED WITH DA VINCI X ROBOT ASSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534387 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] 11 MM TROCAR. COMPLAINT: THE VALVE HAS COME LOOSE. HOW THIS HAPPENED IS A MYSTERY. AS A RESULT, IT HAS ENDED UP LOOSE INSIDE THE ABDOMEN. CONSEQUENTLY, THERE IS NO LONGER ANY AIR IN THE ABDOMEN. UNFORTUNATELY, THE DEPARTMENT NO LONGER HAS THE OUTER PACKAGING. ONLY THE (DIRTY) TROCAR REMAINS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28MAY26: THE VALVE HAS COME LOOSE. HOW THIS HAPPENED IS A MYSTERY. AND AS A RESULT, IT ENDED UP LOOSE INSIDE THE BELLY. BECAUSE OF THIS, THERE IS NO MORE AIR IN THE BELLY. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526969 ↗
• MalfunctionJun 1, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC BILATERAL OVARIAN CYSTECTOMY. EVENT DESCRIPTION: ISSUE: TROCAR TIP BROKEN DURING OPERATION. TROUBLESHOOTING: SEARCH INTO ABDOMINAL CAVITY N IRRIGATION 3L NS. PHYSICAL ISSUE: BROKEN TROCAR CAN BE SEEN. BROKEN PART CAN HURT PT INTERNAL ORGANS. INTERVENTION: TROUBLESHOOTING: SEARCH INTO ABDOMINAL CAVITY N IRRIGATION 3L NS. PATIENT STATUS: PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350492 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  PROCEDURE PERFORMED: BSO. EVENT DESCRIPTION: ACCORDING TO THE SURGEON, A VERY SMALL PIECE FROM THE BEVELED EDGE OF THE GREEN SIZE 11 CANNULA FELL INSIDE THE PATIENT¿S BODY, BUT THEY WERE UNABLE TO RETRIEVE IT. THEY TRIED SEVERAL TIMES USING SUCTION IRRIGATION. INTERVENTION: THEY TRIED TO RETRIEVE THE PIECE SEVERAL TIMES USING SUCTION IRRIGATION. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167044 ↗
• MalfunctionApr 29, 2026Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY LAPAROSCOPIC VS OPEN. EVENT DESCRIPTION: TIP OF TROCAR CAME OFF UPON ENTRY. 11/100MM FIOS FIRST ENTRY. PICTURE BELOW WITH DETAILS. I WAS NOT IN PROCEDURE. SPOKE TO DR. AND HE SAID HE WASN¿T BEING FORCEFUL. TIP OF OBTURATOR CAME OFF IN ABDOMEN, AND SCOPE PUSHED THROUGH. WAS ABLE TO RETRIEVE OBTURATOR TIP LAPAROSCOPICALLY. PATIENT WAS NOT INJURED AND DOING OK. HOSPITAL HAS TROCAR TO BE RETURNED HOWEVER NURSE DID NOT GRAB THE PIECE THAT BROKE OFF. ADDITIONAL INFORMATION PROVIDED BY [APPLIED MEDICAL REPRESENTATIVE] ON 23APR2026 VIA EMAIL: FOLLOWING UP ON YOUR QUESTIONS AND SPEAKING DIRECTLY TO [DOCTOR]. ZERO OBTURATOR INSERTED TO ANOTHER CANNULA. THE ONLY TROCAR THAT WAS USED WAS WITH THAT ONE OBTURATOR. NOTICED DURING USE. IT WAS IDENTIFIED WHEN THE SURGEON HAD TROUBLE INSERTING AND PULLED OUT AND TRIED ANOTHER SPOT BECAUSE WAS DIFFICULT TO GO IN. IT WAS JUST THE SCOPE THAT WAS TRYING TO PUSH IT¿S WAY IN. NOTICED IT THEN AND WAS ABLE TO RETRIEVE THE TIP. INSERTED THROUGH THE TISSUE LAYERS OPTICALLY. THE DIFFICULTY FROM INSERTION WAS BECAUSE THE TIP CAME OFF. AGAIN, DIDN¿T NOTICE TILL PULLED OUT AND TRIED ANOTHER PORT SITE. INTERVENTION: WAS ABLE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033919 ↗
• MalfunctionMar 25, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRECTOMY. EVENT DESCRIPTION: DURING A GASTRECTOMY PERFORMED WITH THE [DEVICE NAME], A CFF75 WAS USED AS THE ASSISTANT PORT. AT THE TIME OF CLOSURE, THE TROCAR WAS REMOVED AND IT WAS NOTICED THAT THE DISTAL END OF THE CANNULA WAS CRACKED. THE ABDOMINAL CAVITY WAS INSPECTED WITH THE CAMERA, AND ALL FRAGMENTS WERE RETRIEVED, CONFIRMING THAT NO PIECES REMAINED INSIDE THE CAVITY. IT IS UNCLEAR AT WHAT POINT THE CANNULA CRACKED, BUT IT WAS LIKELY SOMETIME DURING THE LATTER PART OF THE PROCEDURE. VARIOUS INSTRUMENTS WERE INSERTED THROUGH THE PORT, INCLUDING GRASPING FORCEPS, AN [COMPANY] SUCTION DEVICE, AND THE [DEVICE NAME] STAPLER. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED WITH A HOSPITAL INVENTORY, AND THE PROCEDURE WAS COMPLETED. INTERVENTION: REPLACED WITH A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689812 ↗
• MalfunctionMar 11, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THE TIP HAS BROKEN OFF DURING INSERTION. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570013 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAP UNILATERAL SALPINGOOPHERCTOMY AND OMENTBIOPSY. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON 17-FEB-26: NEW SIMILAR INCIDENT ON (B)(6). TODAY THE TIP OF TROCAR BROKE. [NAME REDACTED] HAS TAKEN THIS BOX OUT OF STORAGE AS SHE IS ¿CERTAIN¿ THAT THE PREVIOUS TROCAR CAME FROM THE SAME BOX. SHE WILL RETURN THE TROCAR FROM TODAYS EVENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAILS, ON 20-FEB-26: WE ASKED THE CUSTOMER TO OPEN ONE STERILE TROCAR THAT HAVEN'T BEEN USED AND IT WILL BE RETURNING AS WELL; I SENT SOME PICTURES EARLIER TODAY. WE WILL OF COURSE SEND THEM A NEW ONE FOR THIS. NO PATIENT INJURY, PLASTICS WERE FOUND PREOPERATIVE, AND TO THEIR KNOWLEDGE NO PIECES LEFT IN THE ABDOMEN. PATIENT STATUS IS WELL. THE PLASTIC WAS DISCOVERED AND REMOVED. PROCEDURE WAS LAP UNILATERAL SALPINGOOPHERCTOMY AND OMENTBIOPSY. THE BREAK WAS IDENTIFIED AFTER USE, DURING INSPECTION. ALL PIECES WERE RETRIEVED FROM CUSTOMER. THE TROCAR WAS NOT USED WITH A ROBOT. EXPECTED PRODUCTS RETURNING: 1 UNIT USED IN THE SURGERY (EVENT UNIT); 1 UNIT NOT USED IN THE SURGERY BUT NON-STERILE; UNKNOWN QUANTITY OF STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524582 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON (B)(6) 26: AS THIS HAPPENED 2 MONTHS AGO AND NEITHER HCP THE APPLIED MEDICAL REP SPOKE TO WERE PRESENT DURING THE PROCEDURE, THERE ISN¿T AN OVERLY DETAILED DESCRIPTION OF WHAT HAPPENED. THE BEST WE CAN ASCERTAIN IS, THE SURGEON INSERTED THE SCOPE INTO THE OBTURATOR, THE TIP OF THE OBTURATOR GAVE WAY. THE TIP ENDED UP IN THE PATIENT AND WAS RETRIEVED IMMEDIATELY BY THE SURGEON; THE PATIENT WAS NOT AFFECTED. THE HOSPITAL HAS TAKEN THEIR STOCK OF CFF33 OUT OF CIRCULATION AND AWAIT INSTRUCTION ON HOW TO PROCEED. THE AFFECTED DEVICE IS TO BE COLLECTED FROM THEATRE, CONTACT EMAIL AND ADDRESS BELOW. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON (B)(6) 26: PROCEDURE WAS LAP CHOLE, HIGH BMI PATIENT. BESIDES THE SCOPE, NO OTHER INSTRUMENTS WERE USED AT THE TIME OF THE INCIDENT. IT WAS NOT A ROBOTIC SURGERY. ONE CANNULA WAS INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. PIECES FELL INTO THE PATIENT AND ALL WERE RETRIEVED. THE TROCAR WAS INSERTED WITH ROTATION. PATIENT WAS HIGH BMI, STAFF DON¿T RECALL ANYTHING OUT OF THE ORDINARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520697 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: BROKE OFF INSIDE OF PATIENT. NEEDED X-RAY TO CONFIRM REMOVED FROM PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 18FEB2026 VIA EMAIL (ENTERED BY APPLIED MEDICAL REPRESENTATIVE): THEY MISSPOKE ON WHAT HAPPENED IN THE PROCEDURE. THEY PUSHED THE MESH DOWN THE 11MM TROCAR, AND THE SEAL FELL OFF THROUGH THE OBTURATOR. IT APPEARS THAT THERE WAS NO BENDING IN THE TROCAR JUST A SEAL BEING BROKEN. NO, THE BEND/BREAK DID NOT CAUSE PARTICULATION. YES, ALL PIECES REMOVED FROM THE PATIENT. NO BEND OR BREAK JUST SEAL ISSUE. TROCAR WAS INSERTED PROPERLY. NO DIFFICULTY DURING INSERTION. NO ROBOT. NO, THE OBTURATOR WAS NOT INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491976 ↗

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