MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WEREWOLF FAST SEAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 72290042

Device Problem Noise, Audible (3273)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

Surgeon had the werewolf in his right hand, not engaging the buttons, and a loud pop and an arc of current came from the tips of the werewolf.At no point had the surgeon engaged the current buttons.He stated this had happened at another baptist facility during the trial.This device/product is not safe for use in the operating room.

• Brand Name: WEREWOLF FAST SEAL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 16963067
• MDR Text Key: 315767562
• Report Number: MW5117714
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/24/2023
• Device Model Number: 72290042
• Device Catalogue Number: 72290042
• Device Lot Number: 2106246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White