MAUDE Adverse Event Report: COVIDIEN LP LIGASURE IMPACT THORACIC; LIGASURE VESSEL SEALING SYSTEM

Model Number LF4200T

Device Problems Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problem Tissue Damage (2104)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

The customer reported that during a radical prostatectomy procedure, the jaws of the device could not be reopened while device was applied to patient tissue.To remove the device from the tissue, the surgeon resected the tissue directly adjacent to the device jaws.There was no injury to the patient.Further, upon receipt of the device at covidien for evaluation, a preliminary investigation found that the knife blade is protruding from the jaws of the device.

Manufacturer Narrative

(b)(4).The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).One used device was received for evaluation.Visual inspection found the knife was protruding from the jaws.The jaws would not open or close due to the protruding knife.The customer's reported condition was confirmed and attributed to user error.Knife trap happens when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have reduced the difficulty in activating the knife.Per the ifu, the jaws should be closed and locked before activating the cutter.A device history review was completed and no entries pertinent to the customer's report were noted.

• Brand Name: LIGASURE IMPACT THORACIC
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); bldg. 10, 789 puxing rd.; shanghai CO 80301 201; CH 80301 2011
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4198008
• MDR Text Key: 5039173
• Report Number: 1717344-2014-00927
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: LF4200T
• Device Catalogue Number: LF4200T
• Device Lot Number: S3MF005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR