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

Model Number CA500

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Surgeon was attempting to clip the bile duct and artery, had to use multiple clips, and they kept falling off.There were several loose that had to be retrieved.Surgeon had to use an endoloop to secure the clipped area.

• 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: 11347810
• MDR Text Key: 232536997
• Report Number: 11347810
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 1400101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 185