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

Model Number	CFB33
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: hysterectomy.Event description: during insertion, the trocar did not engage.It was necessary to convert the procedure to open surgery due to perforation of a large blood vessel, requiring the intervention of the vascular team.After conversion to open surgery, the patient remained in recovery in the uti, due to bleeding, requiring blood transfusion.The trocar was discarded due to contamination.Intervention: converted to open surgery.Patient status: after conversion to open surgery, the patient remained in recovery in the uti, due to bleeding, requiring blood transfusion.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the event unit, it is difficult to determine if the reported event was caused by a device 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.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: hysterectomy.Event description: during insertion, the trocar did not engage.It was necessary to convert the procedure to open surgery due to perforation of a large blood vessel, requiring the intervention of the vascular team.After conversion to open surgery, the patient remained in recovery in the uti, due to bleeding, requiring blood transfusion.The trocar was discarded due to contamination.Additional information provided by [distributor] on 10feb2026 via email: unfortunately, the hospital is not responding to messages because we questioned the use of a product that was already expired.Additional information provided by [distributor] on 11feb2026 via email: yes, the abdomen was insufflated at the time the event unit was inserted.We don't have knowledge if they were able to activate the device so the red indicator was showing before use.We don't have knowledge if the shield of the event unit deployed upon entering abdomen.¿uti¿ stands for icu.Intervention: converted to open surgery.Patient status: after conversion to open surgery, the patient remained in recovery in the uti, due to bleeding, requiring blood transfusion.

• 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: 23759998
• Report Number: 2027111-2025-00907
• Device Sequence Number: 18640231
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2025
• Device Model Number: CFB33
• Device Catalogue Number: 101246001
• Device Lot Number: 1458485
• Was Device Available for Evaluation?: No
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown