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

Model Number	CTR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: na (the units were not used in a clinical setting) event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3: (b)(4).Plastic tab on cannula that is pushed in to remove seal housing broke upon demonstration please note, the units were not used in a clinical setting.The devices were used for several education tables as well as in-services held between 2/16/2025-5/01/2025.The demos took place at cleveland clinic.I only have one saved sterile packing that shows a lot number of 1533196 (material # for that lot is 101219401).Patient status: na (the units were not used in a clinical setting).
Event or Problem Description
Procedure performed: na (the units were not used in a clinical setting).Event description: plastic tab on cannula that is pushed in to remove seal housing broke upon demonstration please note, the units were not used in a clinical setting.The devices were used for several education tables as well as in-services held between 2/16/2025-5/01/2025.The demos took place at [hospital name].I only have one saved sterile packing that shows a lot number of 1533196 (material # for that lot is 101219401) additional information provided by applied medical representative on 16may2025: unsure whether the lot number of the devices that malfunctioned was the same as the sterile unit that is available.No procedure being performed during demonstration.No concomitant devices used during demonstration.Bend/break occurred on the obturator tabs.The bend/break was identified during demonstration of product.Patient status: na (the units were not used in a clinical setting).
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records was performed, and no trends was identified.

• 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: 22027765
• Report Number: 2027111-2025-00530
• Device Sequence Number: 8123251
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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
• Device Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1533196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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