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

Model Number SCD48

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

The device worked for a short time then just quit.Staff changed batteries but the device still didn't work.Staff had to get a new one.No patient harm.

• Brand Name: SONICISION CORDLESS ULTRASONIC DISSECTOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8607336
• MDR Text Key: 144983704
• Report Number: 8607336
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 83050104X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA