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

Catalog Number LS1020

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure to Anastomose (1028)

Event Type  malfunction  

Event Description

The customer reported that the device would not seal the tissue completely.It is unknown if a regrasp alarm or an endtone (indicating a completed seal cycle) was heard.No other information was available regarding this incident.

Manufacturer Narrative

(b)(4).The site has indicated that the incident sample has been discarded.If additional information 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 2011 14; CH 201114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); building 10 789 puxing road; shanghai 0000 2011; CH 000020111
• Manufacturer Contact: sharon murphy, sr. director pmv ; 5920 longbow drive; boulder, CO 80301-0000 ; 2034925267
• MDR Report Key: 3938822
• MDR Text Key: 21490504
• Report Number: 3006451981-2014-00647
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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 Catalogue Number: LS1020
• Device Lot Number: S3M0006X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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