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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure: lap chole event description: additional information provided via phone by an applied medical representative on 07aug2026: once clip placed on artery, it was loose.You can actually move the clip.It had a wiggle.This is not the first time it has happened, but we wanted to give the product a fair chance.Additional information provided via email by an applied medical representative on 12aug2026: dr.(b)(6)]" did not mention that she had any leakeage.In the meeting, she stated that she had a clip scissored on the duct.She took it out, fired the device again and it closed properly.I asked if she had any situations with the closure of the tip and she answered that at times she sees that the clip does not closes well at the apex but in this case it closed properly.Please note that the information entered under dr.(b)(6) actually was said by dr.(b)(6).What dr.(b)(6) did do is agree to his statement.I asked why she agreed, and she responded that it has happened to her but when it does she takes it out and fires again the device.This was reported not within the time frame expected.Months after.Therefore they cant recall.No leakage.The event date is unknown.Intervention: ni patient status: fine.
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.

• 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: 50594094
• Report Number: 2027111-2026-00710
• Device Sequence Number: 9451630
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 09/03/2026

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 Catalogue Number: 101474072
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Trocar and scissor
• Patient Sex: Unknown