MAUDE Adverse Event Report: COVIDIEN LP LIGASURE BLUNT TIP LONG LAP SEALER/DIVIDER; LIGASURE VESSEL SEALING SYSTEM

Model Number	LF1644
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference # : (b)(4).Date of initial report : 06/21/2016.One used lf1644 was received for evaluation.Visual inspection found the cord cut off.The reported condition was not confirmed.Inspection found the cord was cut short and could not be spliced to test for activation.
Event or Problem Description
The customer reported that while performing a sleeve gastrectomy bleeding was noted.End tones, indicating a complete seal cycle, were provided by the generator in use.The blood loss was described as minimal and there was no patient injury.A new instrument of the same type was opened and used to successfully complete the procedure.

• Brand Name: LIGASURE BLUNT TIP LONG LAP SEALER/DIVIDER
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5738108
• Report Number: 1717344-2016-00530
• Device Sequence Number: 947234
• Product Code: GEI
• UDI-Device Identifier: 10884521210868
• UDI-Public: 0110884521210868172009011052400146X
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142929
• 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): 05/26/2016

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: 09/01/2020
• Device Model Number: LF1644
• Device Catalogue Number: LF1644
• Device Lot Number: 52400146X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Initial Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 63