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

Model Number	CTR33
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap subtotal gastrectomy.Event description: right after opening the trocar product, the trocar optulator was broken into two parts and they replaced and used the new product.Product is available for return.Type of intervention: the case was completed with the new device.Patient status: no patient status provided, event occurred before use.
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: lap subtotal gastrectomy.Event description: right after opening the trocar product, the trocar optulator was broken into two parts and they replaced and used the new product.Product is available for return.Type of intervention: the case was completed with the new device.Patient status: no patient status provided, event occurred before use.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainants' experience of a fractured obturator shaft.The obturator wall thickness near the fracture location was measured and it met current specification.Based on the condition of the returned unit, it is possible that the obturator shaft fracture was due to material abnormality which made the obturator more susceptible to fracture.It is also possible that the obturator may have fractured as a result of mishandling during shipping.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were 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: 21074376
• Report Number: 2027111-2025-00302
• Device Sequence Number: 6907667
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2025
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1467540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Patient Sex: Unknown