MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) LIGASURE IMPACT; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LF4200

Device Problems Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

The customer had reported that during a liver resection, the knife blade of the device went out of its track and jammed the jaws of the device such that the jaws could not be opened.The device was not applied to patient tissue when the jaws jammed shut, and there was no harm to the patient.Upon receipt of the device for evaluation at covidien, a preliminary investigation found that the device was received back with the knife blade protruding from the jaws.

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.

• Brand Name: LIGASURE IMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); building 10 789 puxing road; peoples republic of china; shanghai 2011 14; CH 201114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); building 10 789 puxing road; peoples republic of china; shanghai 0000 2011; CH 000020111
• Manufacturer Contact: sharon murphy, sr. dir. pmv ; 5920 longbow dr.; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4077622
• MDR Text Key: 4744159
• Report Number: 3006451981-2014-00708
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: LF4200
• Device Lot Number: S3LF002X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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