Kii Fios First Entry CFF05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915123123), received between Mar 2, 2017 and Nov 7, 2024 — classified as 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Material Fragmentation; Material Fragmentation

  THE EVENT DATE IS UNKNOWN. PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY EVENT DESCRIPTION: A SMALL PART OF THE PLASTIC PORT BROKE OFF. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 22NOV24: THE BREAK OCCURRED ON THE TIP DURING USE. THE TROCAR WAS INSERTED WITH THE CORRECT ROTATION. THERE WAS DIFFICULTY DURING INSERTION. CLEAN BREAK. THE PIECE WAS RETRIEVED FROM THE PATIENT. NO ROBOT. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 2DEC24: THE CODE AND LOT NUMBER WAS GIVEN TO ME BY THE THEATRE COORDINATOR VIA EMAIL AND WHEN I COLLECTED THE PRODUCT IT WAS SEALED IN A BAG AND BLOODY SO I DID NOT OPEN IT TO CONFIRM THE CORRECT CODE UNFORTUNATELY. THEY MUST HAVE MADE A MISTAKE WHEN THEY INITIALLY SENT ME THE CODE. IF YOU LOOK AT THE ORIGINAL PHOTOS THAT WERE SENT IT LOOKS LIKE THE CFF05. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: NO PATIENT HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636496 ↗
• MalfunctionDec 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO #24051 THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: OCTOBER 27,2023 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 - CFF05 LOT #1497048 (1 EA.) . TYPE OF INTERVENTION: NA (INCOMING INSPECTION) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367188 ↗
• MalfunctionAug 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [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: JULY 7,2023. 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 - CFF05 LOT #1487288 (1 EA.). TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646617 ↗
• MalfunctionJan 9, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: (INCOMING INSPECTION) DETAILED DESCRIPTION OF EVENT: [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: NOVEMBER 21,2022 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. 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 - CFF05 LOT #1461377 (1 EA.) TYPE OF INTERVENTION: (INCOMING INSPECTION) PATIENT STATUS: (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125107 ↗
• MalfunctionJun 19, 2020Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LADG. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. DETACHMENT OF THE SEPTUM. REPORT FROM THE SALES REP THE SEPTUM WAS DETACHED FROM SEAL COMPONENT DURING THE PROCEDURE. THE FRAGMENT WAS RECOVERED FROM THE BODY CAVITY. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM WAS DETACHED FROM THE SEAL COMPONENT. IT WAS FRAGMENTED. THE RETURNED FRAGMENT IS SIMILAR TO THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. THE TYPE OF PROCEDURE WAS UPPER GS SURGERY, LADG. THE OPERATION TIME WAS 3-5 HOURS. THE SURGEON'S SKILL LEVEL WAS MID-CAREER. THE MAIN USAGE OF THE DAMAGED TROCAR WAS AS THE 2ND PORT. [NON-APPLIED] ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE WERE INSERTED/REMOVED INTO/FROM THE DAMAGED TROCAR. THE NUMBER OF INSERTION/REMOVAL WAS 10-30 TIMES. THE DAMAGE WAS FOUND AFTER THE CASE. THE SURGEON(S) AND OR NURSE(S) FOUND THE DAMAGE BY FINDING THE PARTS DURING THE CASE. FELT SOMETHING STUCK. AFTER THE DAMAGE WAS FOUND, REMOVED ALL DAMAGED PARTS. INTRAPERITONEAL IRRI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174740 ↗
• MalfunctionJan 22, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM AOMORI OLYMPUS EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: AUGUST 9 2018. 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. PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. POUCH TORN: (B)(4). SCRATCH ON POUCH: (B)(4). TIP DEFORMED: (B)(4). CONCOMITANT DEVICE: NA. PATIENT STATUS: NA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269453 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN - "PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTOMY. THE KII FIOS 5X75MM PORT WAS INSERTED INTO THE PATIENTS ABDOMEN. A SMALL GRASPING FORCEPS WAS INSERTED DOWN THE PORT, THE SEAL WAS PUSHED OUT INTO THE PATIENT'S ABDOMINAL CAVITY. PRODUCT ISOLATED FOR RETURN." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6372210 ↗