MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION Epix® Universal Clip Applier; Clip, Implantable

Model Number	CA500
Medical Device Problem Codes	Failure to Align (2522); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clip applier misaligning clips after 2-3 firings.

• Brand Name: Epix® Universal Clip Applier
• Common Device Name: Clip, Implantable
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rsm CA 92688
• MDR Report Key: 50525861
• Report Number: 50525861
• Device Sequence Number: 15909747
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)290416(30)01(10)1587885
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026
• Report Date (Section F): 08/12/2026

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: CA500
• Device Lot Number: 1587885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2026
• 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: Other
• Patient Sex: Female
• Patient Weight: 141 LB
• Date Report Sent to FDA: 08/12/2026