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)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the event date is unknown.The customer reported that about five or six different clip appliers (likely from the same lot) did not deploy the first (or first and second clip) correctly.There was either no clip or a damaged clip.After some "plastic to plastic" usages the following clips worked just fine.The physicians are trained to use the clipapplier correctly and they are not preloading the clipapplier before entering the trocar.I talked to the chief physician about those incidents and he assured me that he has been using the clip appliers the same way he always had.No clinical impact to the patient as a result of the event.Additional information received from applied medical representative via email on 13-apr-2026: the customer purchased it as a kit.Event dates are different, basically in the 3 weeks prior to the event date.I can not confirm if all the incident devices belonged to lot 1559037.But the customer told me that they never had issues before or after.They think they all belonged to the same lot.I can not clarify it though.4 of the clip appliers did not apply any clips for the first few "plastic to plastics".1-2 provided damaged clips.Intervention: after multiple "plastic to plastic" usages, the clipapplier worked just fine.Patient status: patient is 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 ; 9497135359
• MDR Report Key: 24960623
• Report Number: 2027111-2026-00513
• Device Sequence Number: 16000208
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: APPLIED 5MM TROCAR
• Patient Sex: Unknown