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

Model Number	CA500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Fire (2610); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: cholecystectomy event description: the event date is unknown.In the revision prior the surgery, the clip was delivered with a deformation.By the second revision the clips were stuck in the release area.Service description - requested inspection (performed by hospital from (b)(6) 2026): a technical verification was performed on an epix model ca500 universal disposable clip applier, corresponding to lot 1561350, following an incident reported during a surgical procedure involving patient [name].During the surgical procedure, medical personnel reported anomalous behavior of the device¿specifically regarding the clip release mechanism¿evidencing the ejection of at least one deformed clip, which compromises its proper application and fixation onto the tissue.Additionally, personnel reported that the two devices of the same model requested for the procedure¿both belonging to lot 1561350¿exhibited the same irregular behavior.As a result of this situation, the decision was made to replace them and continue the procedure using an alternate device provided by the medical personnel themselves.As part of the post-event analysis, a functional verification was conducted.During this evaluation, intermittent jamming was identified within the firing mechanism; it was observed that clip release required two to three consecutive trigger pulls for each effective firing.Furthermore, momentary system blockages were detected, affecting the operational continuity and precision of the device.Additionally¿and as documented in the attached photographs obtained during the inspection¿it was noted that the actuator (trigger) failed to return completely after firing, tending to remain in an intermediate position.Intervention: as a result of this situation, the decision was made to replace them and continue the procedure using an alternate device provided by the medical personnel themselves.Patient status: no patient injury reported.

• 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: 25166960
• Report Number: 2027111-2026-00553
• Device Sequence Number: 10643698
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 1561350
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 07/14/2025
• 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
• Patient Sex: Unknown