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

Catalog Number SCD396

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

The sonicision device would not come on and did not work.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 4143115
• MDR Text Key: 16857541
• Report Number: 4143115
• 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: 10/03/2014

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: Nurse
• Device Catalogue Number: SCD396
• Device Lot Number: 42392749X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2014
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 128