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

Model Number LF1937

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

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

Event Date 12/31/2021

Event Type  malfunction  

Event Description

A laparoscopic ligasure device was opened to the sterile field and was attempted to be used on a patient during laparoscopic appendectomy.The first time the jaws were engaged and attempted to be used, the power generator device made a sound and displayed an error message.The device was checked and the jaws became dislodged and were no longer operable.No harm appears to have occurred to the patient.The device was set aside and a replacement was opened and worked as intended.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15410490
• MDR Text Key: 299778054
• Report Number: 15410490
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LF1937
• Device Lot Number: 11810218X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1