MAUDE Adverse Event Report: COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE SONICISION; INSTRUMENT ULTRASONIC SURGICAL

Lot Number 255473X

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

Harmonic (sonicision cordless ultrasonic dissector, ref# scd396, lot#255473x) did not work during the case.Two different batteries were placed and it was the device that did not turn on.This prolongs the surgery when trying to figure out why it malfunctioned.Device was placed in a labeled bag for further evaluation in the decontamination room.Will be sent out for evaluation and credit from vendor.Event did not reach patient.No harm to patient.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE; 5920 longbow dr; boulder, CO 80301
• MDR Report Key: 3601333
• MDR Text Key: 16917110
• Report Number: 3601333
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 255473X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2014
• Patient Sequence Number: 1