MAUDE Adverse Event Report: COVIDIEN SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Lot Number 02820035X

Device Problems Output Problem (3005); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Sonicision stopped working, we change the battery and did solve the problem.A red light was flushing every time surgeon was trying to use it and malfunction noise was noted.Sonicision curved jaw cordless ultrasonic dissector lot 02820035x, exp date: 10112025 ref: scda39.Fda safety report id# (b)(4).

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11596062
• MDR Text Key: 243464162
• Report Number: MW5100422
• Device Sequence Number: 1
• Product Code: LFL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 02820035X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR