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

Model Number SCD48

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

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

Event Date 07/18/2016

Event Type  malfunction  

Event Description

Device did not operate or turn on.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5924257
• MDR Text Key: 53794075
• Report Number: 5924257
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

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 Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 50280136X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1