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 To Patient Tissue Incorrect (1209)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of initial report: 09/09/2016.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.
Event or Problem Description
The customer reported that the device was not sealing correctly even though end tones were heard.Blood loss from the gastric branches of the epiploic vessels was 30-70 ml as a result.There was no injury to the patient.
Additional Manufacturer Narrative
(b)(4).The reported condition that the device would not seal was not confirmed.The device was activated on porcine kidney tissue with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The investigation found the device to function normally and within specifications.Manufacturing non-conformance review is not required since the lot number is unknown.

• 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: 5940697
• Report Number: 1717344-2016-00839
• Device Sequence Number: 16246953
• Product Code: GEI
• UDI-Device Identifier: 10884521210868
• UDI-Public: 0110884521210868172007011051860056X
• 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,Followup
• Report Date (Section B): 08/17/2016

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: 07/01/2020
• Device Model Number: LF1644
• Device Catalogue Number: LF1644
• Device Lot Number: 51860056X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 09/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1