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

Model Number	LS3092
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).One used ls3092 was received for evaluation.Visual inspection found one broken and missing snap from the electrode jaw.The customer reported that the device stopped working.The reported condition was not confirmed.The device was tested for activation on simulated tissue.The device tested normally with visually acceptable seals and end tones indicating completed seal cycles.The investigation found the device to function normally and within specifications.No failure mode was identified.An additional failure was found during the investigation.The additional findings did not contribute to the reported condition.The investigation found one broken snap on the electrode jaw.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly prior to use.This damage can also be caused by multiple assembly attempts.
Event or Problem Description
The customer originally reported that the device stopped working during an abdominal hysterectomy.Another device of the same type was opened and used to complete the procedure.The device was returned for evaluation with a broken and missing snap pin.

• Brand Name: LIGASURE HS MAX DISP ELECT/CORD
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder
• MDR Report Key: 5751068
• Report Number: 1717344-2016-00558
• Device Sequence Number: 18838228
• Product Code: GEI
• UDI-Device Identifier: 10884524002156
• UDI-Public: 0110884524002156
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: LS3092
• Device Catalogue Number: LS3092
• Device Lot Number: 52100162X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2016
• Initial Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other