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); Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: 12/22/2016 one used ls3092 ligasure device was received, and evaluation of the returned sample could not confirm the reported issue with sealing.The device was activated multiple times on simulated tissue as well as porcine kidney samples, pressing the button in various locations on a range of vessel sizes to detect any activation issues.All seal cycles were completed satisfactorily, and a visual seal effect with an end tone was observed for each application.However, an alternate and non-contributing issue was identified.Visual inspection found one of the snaps on the jaw was broken and missing.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.The lot number was not provided, so a review of the device history records could not be performed.
Event or Problem Description
The customer reported that during a j-pouch bowel resection, no thermal spread was observed when the device was activated.No patient injury resulted and a new device was used to continue the procedure.A sealing tone was heard, but it is unknown if an end tone or regrasp alarm occurred.Examination of the received device on december 9, 2016 found one of the snaps on the jaw was broken and missing.The customer reported that no pieces fell into the patient cavity.

• 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: 6200299
• Report Number: 1717344-2016-01196
• Device Sequence Number: 52170
• Product Code: GEI
• UDI-Device Identifier: 10884524002156
• UDI-Public: 0110884524002156
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/22/2016

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 Model Number: LS3092
• Device Catalogue Number: LS3092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1