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

Model Number LF5637

Device Problems Self-Activation or Keying (1557); Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the ligasure l hook was plugged into a generator.At first, there was no energy with the hook, but then staff in the operating room realized the monopolar plug was not all the way in the receptacle for monopolar 2.Upon pushing the monopolar plug in, energy was able to be delivered and the case was continued.Ligasure while in patient and l hook out for use, activated without the attending surgeon pushing the grey button.Attending surgeon, then pushed the grey button and the energy delivery stopped.The doctor then pushed on the grey lever to switch to the vessel sealing jaws and then the l hook was jammed into the jaw of the vessel sealer.The surgeon tried to switch between l-hook and vessel sealer and instrument became stuck in a fixed position.The device did not lock on tissue.The instrument was then removed and taken off the surgical field.They used a ligasure maryland device and laparoscopic l-hook to finish the case there was no patient injury.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 11600507
• MDR Text Key: 243318017
• Report Number: 1717344-2021-00492
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: 10884521521735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1