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

Model Number CA500

Patient Problem Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

Epix universal slip applier by applied medical reorder # (b)(4).Clip applicator was used for the robatic assited whipple procedure.The clips would fire one or two clips then get jammed.Two clip appliers were opened and both misfired.Reference report: mw5146837.

• Brand Name: EPIX UNIVERSAL SLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES
• MDR Report Key: 17922461
• MDR Text Key: 325798403
• Report Number: MW5146836
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CA500
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian