MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	LF1844
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a bariatric procedure (mini gastric bypass), the device was not sealing vessel.It continued with the sealing but did not seal as well.Before getting into trocar, they always checked that energy was delivered and machine was ready to use.During this they used gauge piece and the same happened.They then tried once in to the trocar on patient but same thing continued.It happened in or (operating room) itself but there was no trouble to patient due to the device issue as it did not seal.There was no end tone.Seal cycle continued and doctor left the seal and then error sound was heard.There was not much bleeding as doctor is a user of ligasure since last many years and blade was not run without ending the cycle.Doctor tried 3-6 times on different tissues but it did not seal.Tissue bundles were grasped properly and wasn't that thick as he was separating on omentum part.Procedure was completed with another ligasure probe.There was no patient injury.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12292112
• Report Number: 1717344-2021-01115
• Device Sequence Number: 19750472
• Product Code: GEI
• UDI-Device Identifier: 10884521705890
• UDI-Public: 10884521705890
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K162941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2021

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 Expiration Date: 10/31/2023
• Device Model Number: LF1844
• Device Catalogue Number: LF1844
• Device Lot Number: 83050225X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2021
• Initial Report FDA Received Date: 08/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1