MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) LIGASURE ATLAS HANDSWITCHING 20CM; LIGASURE VESSEL SEALING SYSTEM

Catalog Number LS1020

Device Problems Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2014

Event Type  No Answer Provided  

Event Description

The customer reported that prior to use on a patient, when the surgical staff tested the open and close function of the device jaws, the knife blade was found to be partly detached and was protruding from the device jaws.The blade was still attached to the device, but was not functional.

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.

Manufacturer Narrative

(b)(4).One used ls1020 device was received for evaluation.Visual inspection found the jaw pin was missing, allowing the jaws to misalign, thus exposing the loose knife blade.Covidien confirmed the customer's report.The sample was forwarded to engineering for further evaluation.Engineering researched the parts from the reported lot number, and found that all parts had passed incoming inspection.In addition, no other devices that received jaw pins from this lot number have been reported as having loose knives and/or missing jaw pins.No trend has been identified for this issue.The investigation identified the root cause of the reported event to be an assembly error, and the appropriate personnel were notified.

• Brand Name: LIGASURE ATLAS HANDSWITCHING 20CM
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); 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 ; 5920 longbow drive; boulder, CO 80301-0000 ; 2034925267
• MDR Report Key: 4186166
• MDR Text Key: 4968595
• Report Number: 3006451981-2014-00689
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: LS1020
• Device Lot Number: S4A0029X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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