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

Model Number CA500

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

When surgeon was using the laparoscopic epix universal applier, the clips did not align properly and misfired.No harm to patient during this incident.A new clip applier was used.The procedure was completed.We have the device in case manufacturer would like to further investigate the matter.

• Brand Name: EPIX UNIVERSAL CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 16232381
• MDR Text Key: 308000173
• Report Number: 16232381
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2023

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
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: CA500
• Device Lot Number: 1462857
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 28 KG
• Patient Race: White