MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGACLIP; CLIP, IMPLANTABLE

Model Number ER420

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

Ligaclip was misfiring.One clip scissored shut and the other did not close all the way.Fda safety report id # (b)(4).

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 11285407
• MDR Text Key: 230704756
• Report Number: MW5099233
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: (01)10705036012597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: U9589V
• Was Device Available for Evaluation?: Yes
• 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