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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 Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem Swelling (2091)
Event Date 09/27/2016
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided. No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. The device was received and an evaluation was conducted. The complaint was not confirmed. Device history record review revealed nothing relevant to this event. The evaluation did not reveal anything relevant to the event. The original tubing was not returned. Based on the information provided (and device evaluation), the most likely cause(s) of this type of event is or procedures related to the set-up of the device and tubing did not conform to instructions provided. The labeling for the device and associated tubing, instruction manual for the pump and troubleshooting guide for the device clearly outline the proper set-up procedure and sufficiently warn the user of the potential consequences (extravasation) if instructions for use are not followed. On the tubing package, there is a label instructing the user as follows: warning: do not reconnect tubing for any reason. Reconnecting tubing that was disconnected may cause pump pressure monitoring system errors which may cause extravasation that could result in serious patient injury. In addition to equipment set-up, the operative joint capsule may have already been compromised from prior (pre-operative) injury or trauma. Also, incorrect pressure settings or inter-operative compromising of the joint capsule from other instrumentation could lead to such an event. This is the first complaint of this type for this part/serial number combination. The potential cause(s) of this event will be communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that during a rotator cuff scope the dualwave arthroscopy fluid pump, ar-6480 serial (b)(4) was pumping more pressure into the shoulder than it was supposed to. The settings on the pump were turned down, but there was still a noise coming from the pump. The case was completed and when the patient was undraped the lower portion of the neck and lateral portion of the chest were swollen. The tubing being used with the pump was ar-6410, ((b)(4)). The tubing was discarded by the facility. A sales representative was present for the case and did some trouble shooting with the pump during the case, but was unable to fully resolve the issue. The patient was an (b)(6) female and was kept overnight in the icu for monitoring. It was reported that the patient seems to be doing okay one day post-surgery.
 
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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 Key6043128
MDR Text Key57920939
Report Number1220246-2016-00438
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-6480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2014
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: 10/20/2016 Patient Sequence Number: 1
Treatment
AR-6410, MAIN PUMP TUBING
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