MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: operation performed was a laparoscopy with washout for anterior perforated duodenum.Event description: x2 cff03 were inserted in a paraumbilical position (left and right) and an cor47 was inserted at the umbilicus to achieve laparoscopic access to the peritoneal cavity.Nurse stated [product name] (sharp instrument) was introduced to the cff03 to assist in the deflation of the gall bladder.Whist doing so, the [product name] was inserted at an angle and caught the internal, clear plastic dome of cff03 and was unknowingly advanced through the port into the peritoneal cavity.A clear plastic piece was observed in situ intraoperatively and removed by the attending surgeon.There is no clinical impact to the patient as a result of the event.15.10.2025 additional information received from [applied medical representative] via email: name of the procedure performed? - there is no ¿name¿ for this procedure.As stated on the form, ¿operation performed was a laparoscopy with washout for? anterior perforated duodenum¿.Confirm date of event as 09-feb-2025? - 10th feb 2025.Did the patient injury or illness occur associated with complaint event? - unknown.The hospital has not been approached by the patient requiring a follow up with complaints.Patient status after meeting the surgeon on (b)(6) 2025.¿ as above description of event: confirm if there is only one complaint device? ¿ one cff03 as stated.Intervention: a clear plastic piece was observed in situ intraoperatively and removed by the attending surgeon.Patient status: there is no clinical impact to the patient as a result of the event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainants experience of seal component dislodgement.Based on the description of the event and the photograph provided, it is likely that the reported event was caused by an asymmetrical instrument that was inserted in a non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: operation performed was a laparoscopy with washout for anterior perforated duodenum.Event description: x2 cff03 were inserted in a paraumbilical position (left and right) and an cor47 was inserted at the umbilicus to achieve laparoscopic access to the peritoneal cavity.Nurse stated [product name] (sharp instrument) was introduced to the cff03 to assist in the deflation of the gall bladder.Whist doing so, the [product name] was inserted at an angle and caught the internal, clear plastic dome of cff03 and was unknowingly advanced through the port into the peritoneal cavity.A clear plastic piece was observed in situ intraoperatively and removed by the attending surgeon.There is no clinical impact to the patient as a result of the event.15.10.2025 additional information received from [applied medical representative] via email: - name of the procedure performed? - there is no ¿name¿ for this procedure.As stated on the form, ¿operation performed was a laparoscopy with washout for? anterior perforated duodenum¿ - confirm date of event as 09-feb-2025? 10th feb 2025.- did the patient injury or illness occur associated with complaint event? unknown.The hospital has not been approached by the patient requiring a follow up with complaints.- patient status after meeting the surgeon on (b)(6) 2025.¿ as above.- description of event: - confirm if there is only one complaint device? ¿ one cff03 as stated.Intervention: a clear plastic piece was observed in situ intraoperatively and removed by the attending surgeon.Patient status: there is no clinical impact to the patient as a result of the event.

• Brand Name: KII FIOS FIRST ENTRY
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 23343580
• Report Number: 2027111-2025-00814
• Device Sequence Number: 12714633
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CFF03
• Device Catalogue Number: 101221001
• Device Lot Number: 1508925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "PIG STICKER".
• Patient Sex: Unknown