MAUDE Adverse Event Report: COVIDIEN CLIP APPLIER; CLIP, IMPLANTABLE

Model Number 134051

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Clip applier was being used on femoral artery, when the device was fired, it cut through the artery.All packaging saved and management notified.Fda safety report id # (b)(4).

• Brand Name: CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11723503
• MDR Text Key: 247490129
• Report Number: MW5100964
• Device Sequence Number: 1
• Product Code: FZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P9L1169Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention