MAUDE Adverse Event Report: COVIDIEN LIGASURE; ELECTROSURGICAL, CUTTING; COAGULATION; ACCESSORIES

Model Number LF1637

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2017

Event Type  malfunction  

Event Description

It was noticed during a procedure that a piece of internal spring was exposed on the ligasure hand piece.This ligasure was removed from the field and replaced with a new ligasure.The new ligasure was used to complete the procedure without complication.Per user facility a field technical report was completed and sent to the manufacturer.Manufacturer will issue a return kit.The device will be returned for failure analysis.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING; COAGULATION; ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• MDR Report Key: 6386833
• MDR Text Key: 69361890
• Report Number: 6386833
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LF1637
• Device Catalogue Number: LF1637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 100