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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX DUAL WAVE ARTHROSCOPY PUMP ARTHROSCOPE

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ARTHREX, INC. ARTHREX DUAL WAVE ARTHROSCOPY PUMP ARTHROSCOPE Back to Search Results
Device Problem Defective Device (2588)
Patient Problem Swelling (2091)
Event Date 10/11/2019
Event Type  Injury  
Event Description
Arthrex dual wave arthroscopy pump continually ran during the procedure causing swelling in the arm. Did not respond to pressure feedback within the pump. Rep was present during case. Fda safety report id# (b)(4).
 
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Brand NameARTHREX DUAL WAVE ARTHROSCOPY PUMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
naples FL 34108
MDR Report Key9233701
MDR Text Key163804922
Report NumberMW5090605
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/23/2019 Patient Sequence Number: 1
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