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

Catalog Number SCD396

Device Problem Break (1069)

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

Event Date 09/24/2020

Event Type  Injury  

Event Description

The sonicision cordless ultrasonic dissector broke at the grasper tip during surgery.No injury to patient.Fda safety report id# (b)(4).

• Brand Name: SONICISION CORDLESS ULTRASONIC DISSECTOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10613111
• MDR Text Key: 209585152
• Report Number: MW5096990
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCD396
• Device Lot Number: 00210303X
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68