MAUDE Adverse Event Report: COVIDIEN LLC (SHAGHAI) LIGASUREIMPACT; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LF4200

Device Problems Entrapment of Device (1212); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The customer reported that during a cystectomy/ileal conduit procedure, the jaws of the device could not be reopened while applied to patient tissue.To remove the device from the tissue, the surgeon resected the tissue directly adjacent to the jaws of the device.There was no harm to the patient.Another device was used to complete the procedure.In addition, upon receipt of the device at covidien for evaluation, a preliminary evaluation of the device found that the knife was 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: LIGASUREIMPACT
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LLC (SHAGHAI); building 10 789 puxing road; shanghai 2011 14; CH 201114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); building 10 789 puxing road; shanghai 2011 14; CH 201114
• Manufacturer Contact: sharon murphy, sr. dir ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4213767
• MDR Text Key: 17587114
• Report Number: 3006451981-2014-00697
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• 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: S3LF004X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• 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
• Patient Age: 80 YR