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)
Date of Event	03/27/2026
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: laparoscopic cholecystectomy event description: when placing the clips to clamp the cystic duct: the clips remained open and failed.Consequently, the cystic duct opened, bile leaked into the abdominal cavity, the duration of the procedure was prolonged, and there was an increased risk of a post-operative abscess.The stapler was changed (to a non-automatic stapler and clip cartridges) to continue the procedure.Intervention: the stapler was changed (to a non-automatic stapler and clip cartridges) to continue the procedure.Patient status: patient is fine.

• 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: 24901687
• Report Number: 2027111-2026-00498
• Device Sequence Number: 13264820
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• 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
• Device Catalogue Number: 101474072
• Device Lot Number: 1549538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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