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

Catalog Number AR-6480

Device Problems Fluid/Blood Leak (1250); Output above Specifications (1432); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth, 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.This is one of two submissions for the same patient event.The other is 1220246-2016-00571 ((b)(4)).The device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The pump was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The returned ar-6410 main tubing has a collapsed bladder.Based on the information provided (and no pump 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.Per customer device not being returned.

Event Description

It was reported that the case was shoulder scope, arthroscopic distal clavicle resection and subpectoral tenodesis.During the case, the pump was accelerating, the inflow tube wheel was spinning at a high rate.It was set at 50 (standard setting).The canister was filling with water; it was about 2/3 full.Pressure was high; water was coming out of the cannula.The pump was turned off / on and the problem continued.They then changed out the tubing and the problem was solved.It was then seen that the patient arm from shoulder to elbow turned blue; blood pressure spiked; the swelling went up to the neck, down the back and into the stomach.They aborted the plan to do a arthroscopic distal clavicle resection.A sonogram was performed to check on lungs / vocal chords.Vitals were good; they did a subpectoral tenodesis as planned.The patient is being kept overnight.Patient male, (b)(6).Additional information obtained 12/12/16: pump being used was ar-6480.Per reporter the pump has been checked by the facility's surgery maintenance and is deemed functional.If any additional incidence occurs the facility will return the pump at that time.Facility believes it was the pump tubing and have removed all additional tubing of the same lot out of their inventory.The surgeon provided an update to the reporter.Surgeon confirmed the patient is doing fine and patient went home the next day after the procedure.Surgeon has not gone back to do the patient's distal clavicle and does not have the patient rescheduled for any additional 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: 6190694
• MDR Text Key: 62912252
• Report Number: 1220246-2016-00570
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-6480
• Device Lot Number: NX7991UH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR