MAUDE Adverse Event Report: COVIDIEN SONICISION; CORDLESS ULTRASONIC DISSECTOR

Model Number SCD369

Device Problem Loss of Power (1475)

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

Event Date 07/24/2014

Event Type  malfunction  

Event Description

Sonicision dissector stopped.Batteries were changed and the dissector still did not work.A new sonicision was used.The instrument was sent back to the vendor for investigation.There was no injury or adverse outcome to the pt.The product was extended approx 5 minutes while the sonicision was located and put in use.

• Brand Name: SONICISION
• Type of Device: CORDLESS ULTRASONIC DISSECTOR
• Manufacturer (Section D): COVIDIEN; mansfield
• MDR Report Key: 4148927
• MDR Text Key: 4911906
• Report Number: MW5038488
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2014

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: SCD369
• Device Lot Number: 41400143X
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 58