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

Model Number	LF1520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 activation button fell off of the device prior to use.
Additional Manufacturer Narrative
(b)(4).One used ls1037 device was received for evaluation.Visual inspection confirmed the button had disengaged, and that the device body was damaged.The button was returned with the device.Inspection identified a crack in the body of the device near the button that would allow the button to disengage.A stress fracture of this type is from improper handling or dropping of the device.However, investigation of this issue could not reliably determine where and when this damage occurred.Review of the relevant device history records for this lot found no potentially contributing entries, and no trend is associated with this complaint.

• Brand Name: LIGASURE BLUNT TIP OPEN SEALER/DIVIDER
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5420554
• Report Number: 1717344-2016-00121
• Device Sequence Number: 351612
• Product Code: GEI
• UDI-Device Identifier: 10884521125520
• UDI-Public: 0110884521125520
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/14/2016

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: 09/30/2018
• Device Model Number: LF1520
• Device Catalogue Number: LF1520
• Device Lot Number: 32520097X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2016
• Supplement Report FDA Received Date: 04/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1