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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHROSCOPE

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ARTHREX, INC. DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHROSCOPE Back to Search Results
Catalog Number AR-6480
Device Problems Display or Visual Feedback Problem (1184); Output above Specifications (1432)
Patient Problems Overdose (1988); Swelling (2091)
Event Date 07/26/2016
Event Type  Injury  
Manufacturer Narrative
Maude report did not contain reporter contact information or facility/patient demographics. No additional adverse consequences have been reported from this event. This device is used for treatment. Serial number was not provided on the maude report. No device malfunction identified. At this time, it cannot be determined if the device may have caused or contributed to the patient's experience. An evaluation of the device cannot be performed as the device was not returned to arthrex. No follow up could be performed. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Unable to contact initial maude reporter.
 
Event Description
During a monthly maude review, it was discovered that a user facility had reported the following incident: during the arthroscopic diagnostic part of an acl reconstruction, the ar-6480 pump malfunctioned. The pump never displayed a change of pressure (was always between 30-35) but continued to run at a high speed for a very short time. All the fluid from two 3-liter bags went into the patient. The pump was stopped. The patient's leg became swollen and could not be flexed. Surgeon made the decision to abort the acl procedure. The incision was closed and dressing was applied. The patient was taken to pacu where her leg was still swollen but softer to touch. Patient was observed overnight and was then discharged home in stable condition. Per user facility policy, the device and tubing were sent for inspection. No initial user facility medwatch reporter contact information or facility information was available on the maude report. No follow up will be possible.
 
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Brand NameDUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
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, sr. mdr analyst.
1370 creekside boulevard
naples, FL 34108-1945
8009337017
MDR Report Key5995138
MDR Text Key56332844
Report Number1220246-2016-00407
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-6480
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2016
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/03/2016 Patient Sequence Number: 1
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