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

Model Number 5MM-39CM

Device Problem Loss of Power (1475)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

The product would activate and then stop.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 4732489
• MDR Text Key: 18544891
• Report Number: 4732489
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/07/2014

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 Model Number: 5MM-39CM
• Device Catalogue Number: SCD396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 94