MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC LIGASURE ATLAS HANDSWITCHING 20CM; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LS1020

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 01/22/2014

Event Type  Injury  

Event Description

The customer reported that after a sigmoid resection, the surgeon noticed intraoperative a secondary bleeding from the artery mesenterica superior.A re-laparotomy was necessary.The vessel was transfixed and the bleeding was stopped by suture.Blood loss of more than 250cc was reported.

Manufacturer Narrative

(b)(4).The site has indicated that the incident sample has been discarded.Add'l questions in regard to the incident have been asked.If add'l info pertinent to the incident is obtained, a follow-up report will be submitted.

• Brand Name: LIGASURE ATLAS HANDSWITCHING 20CM
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC; building 10 789 puxing road shanghai; peoples republic of china; 0000 ; CN 0000
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC; building 10 789 puxing road shanghai; peoples republic of china; 0000 ; CN 0000
• Manufacturer Contact: sharon murphy, sr director ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 3625115
• MDR Text Key: 4134298
• Report Number: 3006451981-2014-00039
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LS1020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 62 YR