MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP.; CLIP APPLIER

Catalog Number CA090

Device Problems Bent (1059); Misfire (2532)

Patient Problem No Information (3190)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

We had to open three 5mm direct laparoscopic clip appliers to finally get one that worked correctly.Two of the clip appliers were misfiring and putting out bent clips.They were not attaching to the tissue.

• Type of Device: CLIP APPLIER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; 22872 avenia empresa; rancho santa margarita CA 92688
• MDR Report Key: 4552995
• MDR Text Key: 5479104
• Report Number: 4552995
• 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: 02/26/2015

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: CA090
• Device Lot Number: 1236870
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2015
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 118