MAUDE Adverse Event Report: COVIDIEN LIGASURE RETRACTABLE L-HOOK LAPAROSCOPIC SEALER/DIVIDE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number LF5637

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Description

Ligasure retractable l-hook laparoscopic sealer was not functioning when plugged into the number 5 ft 10 esu machine.Error message noted.Once ligasure replaced with new one, machine functioned properly.

• Brand Name: LIGASURE RETRACTABLE L-HOOK LAPAROSCOPIC SEALER/DIVIDE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16278900
• MDR Text Key: 308645230
• Report Number: MW5114614
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: LF5637
• Device Lot Number: 22160090X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic