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

Catalog Number LF4200

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

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.

Event Description

The customer reported that the knife blade would not retract and the jaws would not open during the procedure.The device was not applied to the patient's tissue when this occurred.There was no injury.The device was returned to covidien for evaluation and initial inspection discovered that the knife blade was protruding from the jaws.

Manufacturer Narrative

(b)(4).One 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.

• Brand Name: LIGASURE IMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5022541
• MDR Text Key: 24669613
• Report Number: 1717344-2015-00585
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: LF4200
• Device Lot Number: 238524LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• 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