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U.S. Department of Health and Human Services

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

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ARTHREX, INC. ARTHROSCOPY PUMP TUBING ARTHROSCOPE Back to Search Results
Model Number AR-6410
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2020
Event Type  malfunction  
Event Description
Arthroscopy pump tubing had a leak at the hub.
 
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Brand NameARTHROSCOPY PUMP TUBING
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
MDR Report Key10829379
MDR Text Key216185412
Report NumberMW5097807
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAR-6410
Device Catalogue NumberAR-6410
Device Lot Number37378527
Was Device Available for Evaluation? Yes
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

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