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

Model Number	CTB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: during the procedure, it was observed that the trocar was leaking.It was necessary to replace the material with another.Additional information received from applied medical representative via email on (b)(6)2024: the patient's status is stable.The event was completed after replacing the trocar with another.The procedure being performed was a cholecystectomy.A veress needle and an [brand name] clip were used with the trocar.The leak was noticed at the beginning of the procedure.Is it unknown what instrumentation passed through the event unit(s) during the procedure.There was no component damage.Intervention: it was necessary to replace the material with another.Patient status: stable.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged trocar.A cannula wing tab was observed to be missing from the cannula.Based on the condition of the returned unit, it is possible the leakage experienced was caused by the fractured cannula wing tab.However, the exact root cause of the damaged cannula wing tab is unknown.Based upon the initial description of the event, the event of seal leakage is not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical has determined that this event is reportable due to the cannula wing tab fracture.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: cholecystectomy.Event description: during the procedure, it was observed that the trocar was leaking.It was necessary to replace the material with another.Additional information received from applied medical representative via email on 12nov2024: the patient's status is stable.The event was completed after replacing the trocar with another.The procedure being performed was a cholecystectomy.A veress needle and an [brand name] clip were used with the trocar.The leak was noticed at the beginning of the procedure.Is it unknown what instrumentation passed through the event unit(s) during the procedure.There was no component damage.Intervention: it was necessary to replace the material with another.Patient status: stable.

• Brand Name: KII SHIELDED BLADED 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: 21658670
• Report Number: 2027111-2025-00434
• Device Sequence Number: 20919412
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K072674
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: CTB33
• Device Catalogue Number: 101219501
• Device Lot Number: 1507231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: VERESS NEEDLE, LT300 CLIP.
• Patient Sex: Unknown