MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ULTRASONIC SCALPEL WITH ADAPTIVE TISSUE TECHNOLOGY; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report to the reporter states, "malfunction of device".

• Brand Name: ULTRASONIC SCALPEL WITH ADAPTIVE TISSUE TECHNOLOGY
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 16973870
• Report Number: 16973870
• Device Sequence Number: 15113119
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/08/2023
• Report Date (Section F): 05/08/2023

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: N/A
• Device Catalogue Number: HAR9F
• Device Lot Number: 14487464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White
• Date Report Sent to FDA: 05/08/2023