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U.S. Department of Health and Human Services

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

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ARTHREX, INC. MAIN PUMP TUBING ARTHROSCOPE Back to Search Results
Model Number MAIN PUMP TUBING
Device Problem Insufficient Information (3190)
Patient Problem Swelling/ Edema (4577)
Event Date 05/04/2021
Event Type  Injury  
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. If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
It was reported during a shoulder arthroscopy procedure, the patients left shoulder was swelling more than normal after 20 minutes of arthroscopy using ar-6480 dualwave pump and ar-6410 pump tubing. The pump settings were set to 50 on the default shoulder arthroscopy setting. The pump never read error of any kind. The pump was shoulder level at the time of the case. The procedure was completed by ending the arthroscopy and finishing the case through an open incision.
 
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Brand NameMAIN PUMP TUBING
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 Key11872411
MDR Text Key252318511
Report Number1220246-2021-03163
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 distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAIN PUMP TUBING
Device Catalogue NumberAR-6410
Device Lot Number49146493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2021 Patient Sequence Number: 1
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