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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Swelling (2356)
Event Date 05/21/2020
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.
 
Event Description
It was reported during a knee arthroscopy the procedure went very normal and the pump functioned properly without overpressure. The pump was at the same level as the operative site. All readings were normal and there was no excessive fluid noticed from the knee. However after the procedure and before closing it was notice the patients calf was extremely swollen and very hard due to compartment syndrome. A fasciotomy was performed with a four to five inch incision which released the pressure and pure saline came out. This made an immediate relief to the calf area and it soon went back to the same size as the calf on the other leg. The doctor closed up the incision and is confident the problem is resolved. The doctor believes the patient had a tear in the knee capsule which lead to the fluid leaking down to the calf. Additional information obtained 5/21/20: the procedure was on the patient's right leg. The pump used with the tubing was ar-6480, serial number (b)(4). Both the pump and tubing will be returned for evaluation.
 
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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 Key10132993
MDR Text Key194606667
Report Number1220246-2020-01883
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
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 Number36726320
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2020 Patient Sequence Number: 1
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