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

Model Number	CFF75
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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of shield dislodgment and a torn and fragmented septum.The clear component was identified to be the shield, an internal plastic component of the seal.Based on the condition of the returned unit and description of the event, it is likely that the dislodged shield and fragmented septum were caused by the non-axial insertion or removal of asymmetrical instruments through the trocar.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.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• 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: 20306502
• Report Number: 2027111-2024-00845
• Device Sequence Number: 7624124
• Product Code: GCJ
• UDI-Device Identifier: 00607915136659
• UDI-Public: (01)00607915136659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: CFF75
• Device Catalogue Number: 101471079
• Device Lot Number: 1507340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• Patient Sex: Unknown