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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 Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Patient Problems Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/18/2020
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, by the facility risk manager, that a patient was undergoing a scheduled outpatient procedure for a left knee arthroscopy, lateral meniscus debridement vs. Repair. The procedure was taking place (b)(6) 2020. During the procedure the arthrex ar-6480 dual wave arthroscopy pump, serial number (b)(4), exhibited an abnormal sound. Described as a loud grinding noise. Immediate review of the pump showed no alarms and appropriate setup. Arthrex sales rep who was present immediately went to check the device and he removed one of the connected tubings and re-installed. At that point it was determined that the pump was producing excess fluid. The stopcock was opened and excess fluid arched out and the fluid hit a staff member in the head. At this point it was discovered that the patient¿s thigh was rigid and compartment syndrome was diagnosed. The surgery was stopped and the procedure was aborted. Once the issue occurred the arthrex rep contacted the arthrex territory manager who also joined the room the patient required a left thigh fasciotomy with wound vac placement (for compartment syndrome) in the left thigh above the incision. Patient was admitted and underwent subsequent irrigation and drainage of the wound on (b)(6) 2020. Patient was discharged to home (b)(6) 2020 with wound vac. Once the issue occurred the arthrex rep contacted the arthrex territory manager who also joined the room. The following tubings were being used with the pump at the time of incident: ar-6410, arthroscopy pump tubing (lot 40067369) and ar-6430 dual wave outflow tube set (lot 40067372. At this time the patient¿s father has indicated reservations with regard to rescheduling the procedure and no second surgery date has been set.
 
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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 Key10934648
MDR Text Key219165856
Report Number1220246-2020-02385
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 health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Device Lot Number10009955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? No
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: 12/02/2020 Patient Sequence Number: 1
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