MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX® UNIVERSAL CLIP APPLIER; CLIP, IMPLANTABLE

Model Number	CA500
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
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: ni.Event description: when they tried the clip applier, there was inside only one clip.Additional information received from applied medical representative via teams call on 10mar26: all the events took place on march 8th before use.4 devices from lot 1560548 had the same problem (only one clip was inside the device) and they were discarded.Additional information received from applied medical representative via email on 17mar26: i¿ve just checked and the correct lot number is 1567140.Additional information received from applied medical representative via email on 19mar26: the user resolved the situation changing device.Only one clip loaded into the jaws.12 mm trocar was used.The clip was loaded and visible between the jaws of the device, and it was properly seated.No (regarding clip loaded into the jaws prior to the instrument¿s insertion/removal through the trocar) because they tried it before putting inside the trocar.The actuation completed by fully squeezing the trigger ¿plastic to plastic¿ and allowing the instrument to rest.No loaded clip was manually removed from the jaws.They tried again, but it was empty.No other clip inside.Like always, the clip was removed.The clip went out any problem.The problem was that there was only one clip.No resistance.It was like always.Intervention: device replacement patient status: na.

• 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 ; 9497135359
• MDR Report Key: 24721313
• Report Number: 2027111-2026-00463
• Device Sequence Number: 10101924
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K011236
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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
• Device Lot Number: 1567140
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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: 12 MM TROCARS
• Patient Sex: Unknown