MAUDE Adverse Event Report: SMITH AND NEPHEW SUPER TURBOVAC 90; ARTHRO WAND

Model Number 90

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 12/05/2016

Event Type  Injury  

Event Description

During repair of his acl the pt experienced bradycardia as the super turbovac 90 wand was used.

• Brand Name: SUPER TURBOVAC 90
• Type of Device: ARTHRO WAND
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 6266426
• MDR Text Key: 65531439
• Report Number: MW5067341
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 90
• Device Catalogue Number: ASC4250-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR