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

Model Number	LF1212A
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When circulating rn plugged covidien ligasure device into generator.The generator kept giving the error message "instrument not recognized." faulty item immediately removed from operating room.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8666282
• Report Number: 8666282
• Device Sequence Number: 16696134
• Product Code: GEI
• UDI-Device Identifier: 10884521186033
• UDI-Public: (01)10884521186033
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/25/2019
• Report Date (Section F): 05/14/2019

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 Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S4HH027X
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 05/14/2019