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

Catalog Number SCD396

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

The device was opened and did not operate correctly.The battery was intact, but no power.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow dr; boulder CO 80301
• MDR Report Key: 3691967
• MDR Text Key: 17162912
• Report Number: 3691967
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2014

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: Physician
• Device Catalogue Number: SCD396
• Device Lot Number: 25604X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR