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

Model Number LF4418

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 07/31/2018

Event Type  malfunction  

Event Description

An impact ligasure had been used in left radical nephrectomy with ivc thrombectomy case for approximately 3 hours when the surgeon noticed the blade protruding from the jaws of the ligasure.The faulty ligasure was removed from the field and a new ligasure impact was opened to continue the case.

• Brand Name: LIGASURE IMPACT
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7817348
• MDR Text Key: 118286553
• Report Number: 7817348
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 81080184X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA