MAUDE Adverse Event Report: Applied Medical Resources Epix® Universal Clip Applier; Clip, Implantable

Model Number	CA500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Biliary Leak (4820)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: Epix® Universal Clip Applier
• Common Device Name: Clip, Implantable
• 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 ; +1(949)713-5359
• MDR Report Key: 50947549
• Report Number: 2027111-2026-00736
• Device Sequence Number: 10451641
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K011236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1586944
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown