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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE

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ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE Back to Search Results
Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during a knee arthroscopy the patient was filled with 3 liters of water within 5 minutes. The pump has not shown the delivered water correctly. It was further reported that the patient past away due to this issue. Update 28-jan-2021 dw: further information were provided that the patient did not die. The surgeon was able to finish the procedure successfully with a second device with the same part number. The customer reported that it appeared that the pump did not stop building up pressure when the trocar was closed.
 
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Brand NameDW ARTHROSCOPY FLUID MANAGEMENT DEV
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key11313867
MDR Text Key233252446
Report Number1220246-2021-02569
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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