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

Model Number	CTR33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
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: hysterectomy event description: while trying to use it for hysterectomy, the cannula and kii seal housing did not separate well, so they tried to forcibly separate them and it broke.After that, the surgery was proceeded with the new product.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 complainant¿s experience of a broken cannula wing tab.Based on the condition of the returned unit, it is possible that the damage to the cannula wing tab occurred during manufacturing or due to improper handling.However, the exact root cause of the broken cannula wing tab could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: hysterectomy.Event description: while trying to use it for hysterectomy, the cannula and kii seal housing did not separate well, so they tried to forcibly separate them and it broke.After that, the surgery was proceeded with the new product.Intervention: the case was completed with the new device.Patient status: no patient status provided, event occurred before use.

• 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: 20736365
• Report Number: 2027111-2024-00919
• Device Sequence Number: 8363146
• 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): 02/05/2025

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 Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1510036
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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
• Patient Sex: Unknown