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

Model Number COVIDIEN SMALL CLIP #133650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Pa was clipping vein for cabg and the clip tore the vein as it was applied.Clip applier was saved and sent to operating room manager.Covidien small clip #133650.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11723452
• MDR Text Key: 247490478
• Report Number: MW5100960
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COVIDIEN SMALL CLIP #133650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention