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

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	11/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopy cholecystectomy.Event description: during a lap chole surgery, the surgeon put a raytex sponge through the trocar and into the abdomen to help with hemostasis.While underway, the surgical assistant noticed the trocar seal had detached and dropped into the abdomen.They were able to retrieve the piece successfully with no patient injury.Device is not available for return as it was discarded.Applied medical representative currently confirming it was a model cff73 or cfs22.Additional information provided by applied medical representative on 22nov2024 via email : he does not have the lot number, so he said that a replacement will be fine.He¿s going to provide me with a no charge po.He is now saying that he has the item to send back, but not the packaging it came in.Can you please provide me with a shipping label as well as a rga label and i will get that over to him to begin the process of sending it back.Intervention: seal retrieved from abdomen.Patient status: patient is fine.
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.The clear component was identified to be a 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 was caused by the non-axial insertion or removal of asymmetrical instruments.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 documentation was identified.
Event or Problem Description
Procedure performed: laparoscopy cholecystectomy.Event description: during a lap chole surgery, the surgeon put a raytex sponge through the trocar and into the abdomen to help with hemostasis.While underway, the surgical assistant noticed the trocar seal had detached and dropped into the abdomen.They were able to retrieve the piece successfully with no patient injury.Device is not available for return as it was discarded.Applied medical representative currently confirming it was a model cff73 or cfs22.Additional information provided by applied medical representative on 22nov2024 via email : he does not have the lot number, so he said that a replacement will be fine.He¿s going to provide me with a no charge po.He is now saying that he has the item to send back, but not the packaging it came in.Can you please provide me with a shipping label as well as a rga label and i will get that over to him to begin the process of sending it back.Intervention: seal retrieved from abdomen.Patient status: patient is fine.

• 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: 20931142
• Report Number: 2027111-2024-00957
• Device Sequence Number: 12039102
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown