MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII OPTICAL ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
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: unknown.Event description: after incision the trocar was by rotating movements and appropriate pressure placed in the abdominal wall.By passing the tissue, a peace of the sleeve was broken off.The surgeon removed the peace out of the patient by using a grasper.The surgeon first removed the trocar, than he used a grasper to remove the peace out of the patients abdomen.Than he open a new trocar and placed it without problems.No clinical impact.Type of intervention: opened a new trocar and placed it without problems.Patient status: no injury or illness occured.
Event or Problem Description
Procedure performed: unknown event description: after incision the trocar was by rotating movements and appropriate pressure placed in the abdominal wall.By passing the tissue, a peace of the sleeve was broken off.The surgeon removed the peace out of the patient by using a grasper.The surgeon first removed the trocar, than he used a grasper to remove the peace out of the patients abdomen.Than he open a new trocar and placed it without problems.No clinical impact.Type of intevention: opend a new trocar and placed it without problems.Patient status: no injury or illness occured.
Additional Manufacturer Narrative
Wip [correction] updated section d1.Brand name and d4.Primary unique device identification (udi) number.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely that the cannula tip fracture was due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip was more susceptible to fracture.A historical trend analysis and review of production records was performed and no relevant documentations were identified.[correction] updated section d1.Brand name and d4.Primary unique device identification (udi) number.
Event or Problem Description
Procedure performed: unknown.Event description: after incision the trocar was by rotating movements and appropriate pressure placed in the abdominal wall.By passing the tissue, a peace of the sleeve was broken off.The surgeon removed the peace out of the patient by using a grasper.The surgeon first removed the trocar, than he used a grasper to remove the peace out of the patients abdomen.Than he open a new trocar and placed it without problems.No clinical impact.Additional information received from an applied medical representative via email 18oct24: the break occurred on the tip of the sleeve.The trocar was inserted like recommended by rotating clockwise with no difficulty in inserting.The break was considered a clean break.Yes, the break caused particulation with all pieces retrieved.The trocar was not used with a robot.There was no instrument inside of the cannula at the time of the incident.Type of intervention: opend a new trocar and placed it without problems.Patient status: no injury or illness occured.

• Brand Name: KII OPTICAL ACCESS SYSTEM
• 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: 20477220
• Report Number: 2027111-2024-00875
• Device Sequence Number: 8330696
• Product Code: GCJ
• UDI-Device Identifier: 00607915122294
• UDI-Public: (01)00607915122294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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 Expiration Date: 07/10/2026
• Device Model Number: CFR01
• Device Catalogue Number: 101453701
• Device Lot Number: 1497053
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 03/31/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCAPEL.
• Patient Sex: Unknown