MAUDE Adverse Event Report: COVIDIEN SONICISION 7; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SCD7A48
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sonicision 7 handpiece would not close/lock battery in place.Defective device identified and removed from service prior to patient entering or (operating room).

• Brand Name: SONICISION 7
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 20245019
• Report Number: 20245019
• Device Sequence Number: 20653571
• Product Code: LFL
• UDI-Device Identifier: 10884521794801
• UDI-Public: (01)10884521794801
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2024
• Report Date (Section F): 08/27/2024

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 Model Number: SCD7A48
• Device Lot Number: 33550222X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Date Report Sent to FDA: 08/27/2024