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

Model Number LF1937

Device Problems Failure to Fire (2610); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Ligasure maryland jaw laprascopic sealer/divider was utilized during care.This piece of equipment did not operate as intended and would not fire when being utilized by a provider.A second ligasure maryland jaw laprascopic sealer/divider was utilized and also did not operate as intended.Both pieces of equipment were nonresponsive and would not fire when the trigger was pulled.This was tested with two different electrosurgical unit (esu) boxes and the same result occurred both times.Provider refrained from using the malfunctioning equipment on the patient.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15592611
• MDR Text Key: 301738175
• Report Number: 15592611
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705913
• UDI-Public: (01)10884521705913(17)270601(10)21530201X
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Lot Number: 21530201X
• 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: 09/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Sex: Female