MAUDE Adverse Event Report: COVIDIEN LP LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIV; LIGASURE VESSEL SEALING SYSTEM

Model Number	LF1544
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report : (b)(6) 2016.One used lf1544 ligasure device was received for evaluation, and examination of the returned sample could not confirm the reported issue of difficulty opening.Visual inspection found the device was not closed or jammed when received.However, an alternative issue was identified where the device would not latch shut because of broken latch tines within the handle.Investigation of this issue could not reliably determine when or how the tines were damaged.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.
Event or Problem Description
The customer reported that the device would not open during a bypass procedure.There was no injury to the patient.

• Brand Name: LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIV
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5893437
• Report Number: 1717344-2016-00778
• Device Sequence Number: 16300114
• Product Code: GEI
• UDI-Device Identifier: 10884521124875
• UDI-Public: 0110884521124875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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: 03/31/2020
• Device Model Number: LF1544
• Device Catalogue Number: LF1544
• Device Lot Number: 50340051X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Initial Report FDA Received Date: 08/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1