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

Model Number LF5544

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2017

Event Type  malfunction  

Event Description

When the caregiver went to use the product, a piece of metal was noted to be sticking up at the point.A new product was obtained and used instead.Device was not used on the patient and did not cause harm as this was noticed prior to use.

• Brand Name: LIGASURE ADVANCE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6463357
• MDR Text Key: 71847010
• Report Number: 6463357
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/14/2022
• Device Model Number: LF5544
• Device Catalogue Number: LF5544
• Device Lot Number: 70460264X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1