Kii Fios First Entry CFF75Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607915136659), received between Jun 26, 2019 and Mar 25, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC KIDNEY EXTRACTION. EVENT DESCRIPTION: REPORT FROM THE SALES REP VIA EMAIL; THE INNER VALVE WAS DISLODGED DURING INSERTION OF THE RAPALLO GAUZE. THIS UNIT WILL BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 19SEP2024 FROM APPLIED TERRITORY MANAGER: ADDITIONAL QUESTIONS REVEALED THE FOLLOWING INFORMATION THE FOLLOWING INFORMATION WAS OBTAINED FROM ADDITIONAL QUESTIONS. ALL THE OBJECTS THAT FELL OUT OF THE BODY WERE RECOVERED. THE PART THAT FELL WAS THE SHIELD PART. THE ENTIRE SHIELD PART FELL. THE RAPAGORCEPS WERE BEING USED TO INSERT THE RAPAGORCEPS AT THE TIME OF THE INCIDENT. NO PARTS OTHER THAN THE DAMAGED PARTS WERE DISLODGED. TYPE OF INTERVENTION: REPLACED WITH A NEW PRODUCT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306502 ↗
• MalfunctionNov 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED. NA (INCOMING INSPECTION). [DISTRIBUTOR] INCOMING INSPECTION PO #(B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: SEPTEMBER 1,2023. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. ¿) WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. ¿ HAIRLIKE OBJECT IN POUCH - CFF75 LOT #1497051 (B)(4). TYPE OF INTERVENTION. NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067472 ↗
• MalfunctionMay 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). [DISTRIBUTOR] INCOMING INSPECTION PO#: (B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR]EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: MARCH 17,2023. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH: CFF75 LOT#: 1480050 (B)(4) EA.) TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934704 ↗
• MalfunctionDec 10, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM [FACILITY] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: (B)(6) 2021. PLEASE REFER TO THE ATTACHMENT FILE. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. CFF75 LOT 1426342 - HAIRLIKE OBJECT IN POUCH. PRODUCTS AVAILABLE FOR RETURN. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979396 ↗
• MalfunctionOct 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA INCOMING INSPECTION. DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION PO# (B)(6). THIS IS A COMPLAINT FROM [NAME] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: (B)(6) 2021. PLEASE REFER TO THE ATTACHMENT FILE. PHOTOS ARE AVAILABLE. PRODUCTS AVAILABLE FOR RETURN. HAIRLIKE OBJECT IN POUCH - CFF75 LOT # 1420215 (1 EA) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT) TYPE OF INTERVENTION: NA INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579585 ↗
• MalfunctionJan 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: GASTRECTOMY. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP: THE VALVE WAS DROPPED INTO THE BODY DURING THE PROCEDURE. THE PIECE WAS RECOVERED FROM THE BODY CAVITY. THE CASE WAS COMPLETED WITH THE NEW ONE. ADDITIONAL INFORMATION FROM SALES REP: THE SEPTUM AND SHIELD WERE DROPPED WHEN IT WAS TAKEN OUT OF THE BODY. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM AND THE SHIELD WERE DETACHED (PIC.1). NO VISUAL DAMAGE WAS FOUND IN DDB. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11233393 ↗
• MalfunctionJan 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: EVENT 1 OF 2: 2027111 - 2021 - 00302; EVENT 2 OF 2: 2027111 - 2021 - 00301. "FOREIGN MATERIAL IN THE CHECK VALVE." "REPORT FROM THE SALES REP: THE BRAWN FOREIGN MATERIAL WAS FOUND IN THE CHECK VALVE WHEN INSERTED INTO THE BODY AND TRIED TO INJECT THE AIR. THE SAME PRODUCT OPENED THE SECOND TIME WAS DIRTY. THE CASE WAS COMPLETED WITH THE THIRD ONE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. WE CONFIRMED THE BRAWN FOREIGN MATERIAL LIKE A TISSUE IN THE AIR INSUFFLATION PORT (PIC.1). THE OTHER FOREIGN MATERIAL WAS ADHERED ON THE SURFACE OF THE SEAL COMPONENT (PIC.2). THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION." INTERVENTION: THE CASE WAS COMPLETED WITH THE THIRD ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11125508 ↗
• MalfunctionJan 6, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: "FOREIGN MATERIAL ON THE DISTAL END OF THE OBTURATOR" "REPORT FROM THE SALES REP THE BRAWN FOREIGN MATERIAL WAS FOUND IN THE CHECK VALVE WHEN INSERTED INTO THE BODY AND TRIED TO INJECT THE AIR. THE SAME PRODUCT OPENED THE SECOND TIME WAS DIRTY. THE CASE WAS COMPLETED WITH THE THIRD ONE. THIS IS THE REPORT OF THE SECOND CASE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. WE CONFIRMED THE BRAWN FOREIGN MATERIAL LIKE A TISSUE ON THE DISTAL END OF THE OBTURATOR (PIC.1). THE OTHER FOREIGN MATERIAL WAS ADHERED ON THE SURFACE OF THE SEAL COMPONENT (PIC.2). THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. THE COMPONENT LIST WAS PROVIDED AND THE PACKAGING, CANNULA, OBTURATOR, AND SYRINGE ARE AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH THE THIRD ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11124080 ↗
• MalfunctionJun 26, 2019Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(6). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. BALLOON WOULD NOT INFLATE. REPORT FROM THE SALES REP: THE BALLOON WOULD NOT INFLATE WHEN INSERTED INTO A NARROW SPACE. INITIAL INVESTIGATION REPORT BY [DISTRIBUTOR]: THE EVENT UNIT WAS RETURNED TO [DISTRIBUTOR] AND VISUALLY INSPECTED. THE PROXIMAL SIDE OF THE BALLOON WAS FOUND TO BE HOLED (PIC.1). THE DISTAL SIDE OF THE CANNULA WAS SCRATCHED (PIC.2). THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN#: (B)(6). THE COMPONENT LIST WAS PROVIDED AND THE PACKAGE, CANNULA AND OBTURATOR ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 09MAY2019 FROM [DISTRIBUTOR]: UNDER THE VISUAL INSPECTION, TISSUE ATTACHED TO THE SEPTUM, I DIDN'T KNOW FIRMLY IS THERE WAS DAMAGE TO THE CHECK VALVE. METAL RETRACTORS MAYBE WERE USED. THIS WAS NOT A ROBOTIC PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735548 ↗