MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS / COVIDIEN LIGASURE IMPACT WITHOUT NANO-COATING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number 12658305

Device Problems Loss of or Failure to Bond (1068); Failure to Cut (2587); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

During surgery ligasure impact did not function properly.Scissors had issues cutting, jaws had difficulty creating seal.Fda safety report id# (b)(4).

• Brand Name: LIGASURE IMPACT WITHOUT NANO-COATING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS / COVIDIEN
• MDR Report Key: 11874666
• MDR Text Key: 252693263
• Report Number: MW5101511
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Lot Number: 12658305
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR