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	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: [hospital] "during use, there was a problem with shooting." product is available for return.Additional information was received via email on (b)(6) 2026 from [name], territory manager: "the ¿loading the clip¿ action was being performed when the experience occurred.The instrument ¿misfired¿ in that it was struck when the trigger was pulled.A total of 3¿4 clips were dispensed.The incident occurred with 1¿2 clips.When it struck, the surgeon did not try to fix it anymore because it could misfire when the clip applier is inside peritoneum." intervention: the case was completed with the new device.Patient status: there was no problem with the patient.

• 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: 25367695
• Report Number: 2027111-2026-00581
• Device Sequence Number: 9994679
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Expiration Date: 09/24/2026
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1505294
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 09/25/2023
• 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
• Patient Sex: Unknown