MAUDE Adverse Event Report: COVIDIEN LP LIGASURE HS MAX DISP ELECT/CORD; LIGASURE VESSEL SEALING SYSTEM

Model Number	LS3092
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: 10/12/2016.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.
Event or Problem Description
The customer reported that the device was broken within the packaging.The issue was identified during distribution and before use in a procedure.Examination of the device on (b)(6) 2016 found the activation button had detached.
Additional Manufacturer Narrative
(b)(4).One un-used ls3092 ligasure device was received, and evaluation of the sample confirmed the reported issue.Visual inspection found the weld of the body was incomplete.This resulted in an activation button that was not properly secured and the device would easily pull apart.The device could not have been used in this condition.The investigation identified the cause of this issue as operator oversight during manufacture.No trend has been associated with this complaint, and measures are in place to detect the issue during the manufacturing process.Review of the device history records for this lot found no further potentially contributing factors.

• Brand Name: LIGASURE HS MAX DISP ELECT/CORD
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 6024821
• Report Number: 1717344-2016-00950
• Device Sequence Number: 1078376
• Product Code: GEI
• UDI-Device Identifier: 10884524002156
• UDI-Public: 0110884524002156
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: LS3092
• Device Catalogue Number: LS3092
• Device Lot Number: 41350090X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1