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

Catalog Number SCD13

Device Problems Material Twisted/Bent (2981); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

Sonicision cordless ultrasonic dissector not working after battery installed.Battery changed without effect.Dissector changed and working.First instrument noted to have bent prong.Fda safety report id# (b)(4).

• Brand Name: CORDLESS ULTRASONIC DIESSECTOR SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10810299
• MDR Text Key: 215508735
• Report Number: MW5097704
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCD13
• Device Lot Number: 00850233X
• 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: 64 YR