MAUDE Adverse Event Report: ARTHREX, INC. DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE; ARTHROSCOPE

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.

• Brand Name: DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
• Type of Device: ARTHROSCOPE
• 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 Key: 6043128
• MDR Text Key: 57920939
• Report Number: 1220246-2016-00438
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• 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 Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AR-6410, MAIN PUMP TUBING
• Patient Outcome(s): Other