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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 Problem Increase in Pressure (1491)
Patient Problems Nerve Damage (1979); Swelling (2091); Urinary Retention (2119); Injury (2348); Deformity/ Disfigurement (2360)
Event Date 10/04/2018
Event Type  Injury  
Manufacturer Narrative
It was initially reported that the ar-6480 was set at the default 35 setting, but at the surgeon¿s request the pump was increased to 70 for a couple of seconds but then turned back down. Arthrex confirmed there was no surgical intervention to remove the fluid nor was the patient kept overnight due to the fluid retention. It also was initially reported that the patient was discharged the same day. The ar-6480 device was returned to arthrex and an evaluation was completed. The ar-6480 operated within specifications during functional testing and no malfunctions were identified.
 
Event Description
It was reported that during a knee scope procedure, the ar-6480, dualwave pump was increasing pressure and caused a large amount of fluid retention in the patients hip and groin. The rep reported that the ar-6480 was set at the default 35, but at the surgeon's request the pump was increased to 70 for a couple of seconds but then turned back down. The rep stated that this information was provided to him by the surgical staff as the rep was not present during the procedure. Additional information has been requested. Additional information received on 10/08/2018: the rep confirmed that a replacement ar-6480 was used to complete the procedure. The rep stated that just inflow was being used, and the excess fluid was not removed. The rep confirmed that the patient was not kept overnight. The shaver boost percentage was at 25%. The legacy black connecting cord was used to connect the shaver console to the dualwave pump. Additional information received 6/24/2019: per the facility, according to the hospital records available as of 6/24/2019, the doppler done in the or showed all pulses present and a urologist, who was consulted and evaluated the patient, agreed that no further intervention was needed. The patient was discharged the same day as surgery. Additional information received 10/26/20: as reported by the patient¿s legal filing, on 10/4/2018, an arthroscopy was performed to debride a chondral fracture lateral femoral condoyle and removal of an osteochondral loose body. The arthrex dualwave arthroscopy pump was used to pressurize the surgical site during the procedure. It is further alleged in the legal filing by the patient¿s lawyer that the dualwave pump allegedly extravasated saline into the patient's thigh, groin and surrounding tissue and structures causing severe and damaging swelling which resulted in injuries to the patient, including: alleged urinary injury, dysfunction of the systems, nerve damage, and disfigurement.
 
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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 Key10843399
MDR Text Key216418371
Report Number1220246-2020-02342
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
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 Number21711015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
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