MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FASTSEAL 6.0 HEMOSTASIS WAND; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	72290042
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The werewolf fastseal 6.0 hemostasis wand stops while working.It takes multiple presses on the hand piece to make work.Health care provider has pulled off the shelf all the same lot number for the time being.

• Brand Name: FASTSEAL 6.0 HEMOSTASIS WAND
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 14287875
• Report Number: 14287875
• Device Sequence Number: 12114666
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: (01)00885556787229(17)230126(10)2087549(11)220126
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/15/2022
• Report Date (Section F): 04/15/2022

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: 72290042
• Device Catalogue Number: 72290042
• Device Lot Number: 2087549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/15/2022