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

Catalog Number CA500

Device Problems Bent (1059); Failure to Fire (2610)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The clip applier was bent and was not used on the patient because it would not fire.

• Brand Name: EPIX UNIVERSAL CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 4963216
• MDR Text Key: 6192233
• Report Number: 4963216
• Device Sequence Number: 1
• Product Code: FZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/02/2015

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: Physician
• Device Catalogue Number: CA500
• Device Lot Number: 1242808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2015
• Patient Sequence Number: 1
• Patient Age: 65 YR