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

Model Number	CTF73
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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic colon surgery.Event description: the trocar was used as a camera trocar in combination with a 10mm laparoscope of company [name].The surgeon is a long time customer and user of our trocars.During the laparoscopic intervention the surgeon found an inner part of the trocars valve (the transparent centering piece) in the abdomen by chance.He was able to recover and to extract it out of the abdomen.They than replaced the trocar and conserved the damaged trocar in a closed bag.Additional information received by an applied medical representative via email on 18dec2025: the product is conserved at the customer site and can be collected and sent back to amersfoort.Lot number stills unknown as it was not documented and the packaging was thrown away.All pieces were retrieved from the patient.No internal seal components were removed nor cut in order to inspect the damaged component.The trocar was used as a camera trocar.The camera is a 10mm [brand name] laparoscope.Besides that reusable instruments like graspers, scissors and suction-irrigation was used.Also an energy device was involved - as far as i know they only have [competitor energy device] in use.Intervention: the operation was prolonged by a couple of minutes and the trocar had to be replaced.Patient status: patient is well and the event had no known influence on the outcome.
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.

• 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: 23917916
• Report Number: 2027111-2025-00955
• Device Sequence Number: 21092110
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041795
• 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): 05/19/2026

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: CTF73
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 05/19/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM LAPAROSCOPE OF COMPANY STORZ.; GRASPERS, SCISSORS.; SUCCTION-IRRIGATION, ENERGY DEVICE.
• Patient Sex: Unknown