MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) LIGASURE ATLAS HANDSWITCHING 37CM; LIGASURE VESSEL SEALING SYSTEM

Model Number LS1037

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: (b)(6) 2016.One used ls1037 device was received, and evaluation of the returned sample could not confirm the reported issue with activation.Testing of the device found that it functions within all related specifications, and would seal on simulated tissue without issues.However, a separate non-contributing issue of damaged wire insulation was found.The manufacturing process has been reviewed and nothing found that would cause this type of damage.The device history records for this lot were also reviewed and no potentially contributing entries found.Damage of this type is consistent with scraping the jaws against the sharp edge of a trocar during insertion or removal of the device.The ifu included with this product cautions users to carefully insert and withdraw instruments from trocars to avoid possible damage to the devices and/or injury to the patient.

Event Description

The customer reported that during a procedure, the device would not activate.Upon receipt of the device, covidien identified that a piece of the wiring insulation next to the jaws was missing and not returned.The customer has confirmed that the missing piece did not fall within the patient cavity.No patient injury occurred.

• Brand Name: LIGASURE ATLAS HANDSWITCHING 37CM
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); bldg.10, 789 puxing rd.; shanghai 20 11 14; CH 20 1114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); bldg.10, 789 puxing rd.; shanghai 20 11 14; CH 20 1114
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5634710
• MDR Text Key: 45011288
• Report Number: 3006451981-2016-00204
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S4L0030CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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