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

Model Number	CFF01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
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: laparoscopic bilateral ovarian cystectomy.Event description: issue: trocar tip broken during operation.Troubleshooting: search into abdominal cavity n irrigation 3l ns.Physical issue: broken trocar can be seen.Broken part can hurt pt internal organs.Intervention: troubleshooting: search into abdominal cavity n irrigation 3l ns.Patient status: patient injury reported.

• 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: 25350492
• Report Number: 2027111-2026-00580
• Device Sequence Number: 21519703
• Product Code: GCJ
• UDI-Device Identifier: 00607915123147
• UDI-Public: (01)00607915123147
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CFF01
• Device Catalogue Number: 101453601
• Device Lot Number: 1563729
• 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: 05/01/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 09/03/2025
• 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