MAUDE Adverse Event Report: COVIDIEN LP SONICISION CURVED JAW CORDLESS ULTRASONIC DISSECTOR; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCDA39

Device Problem Failure to Shut Off (2939)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

The surgeon pulled the trigger to activate the device and when finished using it he released his finger and the device continued to operate even when his finger was off the trigger.Device was removed and taken off the field without injury to the patient.

• Brand Name: SONICISION CURVED JAW CORDLESS ULTRASONIC DISSECTOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12494726
• MDR Text Key: 272204463
• Report Number: 12494726
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCDA39
• 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: 09/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 121