MAUDE Adverse Event Report: COVIDIEN LP MARYLAND JAW LAP (37CM); LIGASURE VESSEL SEALING SYSTEM

Model Number LF1737

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

Covidien reference # : (b)(4).Date of initial report : 02/01/2017.The site has indicated that the incident sample has been discarded.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The customer reported that during a robotic assisted transaxillary thyroidectomy the surgical technician recognized part of the black coating toward the distal end of the shaft had torn.They were not sure if any of the coating fell off of the shaft.The surgeon searched in the area of the patient where the device was being used as well as in the trocar.They could not find any pieces of coating.There was no patient injury, and no device fragment in the patient cavity.

• Brand Name: MARYLAND JAW LAP (37CM)
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO ; 2034925267
• MDR Report Key: 6294393
• MDR Text Key: 66320581
• Report Number: 1717344-2017-00098
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: LF1737
• Device Catalogue Number: LF1737
• Device Lot Number: 62210272X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1