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

Model Number	LS3112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference #: (b)(4).Date of initial report: 11/03/2016.One used ls3112 ligasure device was received for evaluation, and the reported issue of difficult activation was not confirmed.Testing of the device found it was recognized by the generator and there were no issues with the cord dot-recognition fixture.Sealing was performed multiple times, and all seal cycles were completed satisfactorily with end tones.However, an alternate and non-contributing issue was identified.Visual inspection found one of the snaps on the jaw was broken and missing.Review of the device history records for this lot found no potentially contributing factors.A 100% visual inspection of the snap pins is performed during production, and it is unlikely the product was damaged when it left the manufacturing facility.Snap damage can be caused by misaligning the snaps during assembly by the user or by multiple assembly attempts.The investigation identified the root cause of the damage to be user error.The instructions for use included with this product lists measures for proper assembly.
Event or Problem Description
The customer reported that during a procedure, the device would not activate when the hand switch was used.The device was in use with a forcetriad generator, and the same issue occurred with other devices that were tested.No patient injury occurred.Examination of the received sample on october 31, 2016 found that a snap pin is missing.The customer reported that no part of the device fell within the patient cavity.

• Brand Name: LIGASURE HS XTD DISP ELEC/CORD
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 6077863
• Report Number: 1717344-2016-01020
• Device Sequence Number: 16333222
• Product Code: GEI
• UDI-Device Identifier: 10884524002514
• UDI-Public: 0110884524002514
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/15/2016

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: 02/28/2021
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 60490064X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FORCETRIAD GENERATOR