MAUDE Adverse Event Report: ARTHREX DUAL WAVE

Model Number DUALWAVE

Device Problems Burst Container or Vessel (1074); Increase in Pressure (1491)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  Injury  

Event Description

During arthroscopy the arthrex tubing became high pressurized by itself and was so forceful it burst the pt's capsule.Dr stated this was in a non harmful place and no further treatment of action was needed.I first changed out the arthrex machine and it became high pressurized again.The next action i took was to change out the pump tubing and then proceeded on with the case.The arthrex rep was notified and both the tubing and machine were taken out of use.

• Brand Name: DUAL WAVE
• Type of Device: DUAL WAVE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 6173374
• MDR Text Key: 62466797
• Report Number: MW5066675
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUALWAVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR