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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Report to the reporter states, "malfunction of device".

• Brand Name: ULTRASONIC SCALPEL WITH ADAPTIVE TISSUE TECHNOLOGY
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 16973870
• MDR Text Key: 315680427
• Report Number: 16973870
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• 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
• Date Report Sent to FDA: 05/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White