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

Model Number COVIDIEN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/19/2021

Event Type  Injury  

Event Description

During a mediastinal mass excision on a heart patient in room 15, the surgeon went to use the clip applier in question and the clip crossed and instead of occluding the blood vessel, the clip applier ligated a vessel which was not the intent of the surgeon, i have sequestered the item and will give it to management, in order to fix this situation we opened ethicon clip applier and that satisfied the bleeding vessel.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11723470
• MDR Text Key: 247488041
• Report Number: MW5100961
• 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: COVIDIEN
• Device Catalogue Number: 134051
• Device Lot Number: POM1904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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