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

Model Number LF1837

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

The ligasure" blunt tip laparoscopic sealer/divider lf1837 gave an error after being plugged into the machine.The staff did not documented the error message.The same lf1837 was tried on a different machine giving the same undocumented error.A second ligasure device was opened and worked as expected during the surgical procedure.The manufacturer provided tracking # and product return packaging to obtain the defective device.Uf send the defective device to the manufacturer on (b)(6) 2020.

Event Description

The ligasure¿ blunt tip laparoscopic sealer/divider lf1837 gave an error after being plugged into the machine.The staff did not documented the error message.The same lf1837 was tried on a different machine giving the same undocumented error.A second ligasure device was opened and worked as expected during the surgical procedure.The manufacturer provided tracking # and product return packaging to obtain the defective device.Uf send the defective device to the manufacturer on july 8th of 2020.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10249928
• MDR Text Key: 198101676
• Report Number: 10249928
• 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
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 00560275X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 93