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

Catalog Number AR-6480

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 01/19/2016

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 requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as 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.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 the device is returned and additional information is obtained, a follow-up report will be submitted.Device expected but not yet returned.

Event Description

It was originally reported that the event happened during surgery.Performed procedure was an arthroscopy of the upper ankle joint.The pump was running with a pressure of 35 but the lower leg was continuously flooded with water.Follow-up investigation: compartment syndrome was the outcome.The surgeon had to make an additional cut to get the water out of the lower leg.Surgery was aborted.No further info available.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is a follow-up submission to reflect the device evaluation.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.Device history record review revealed nothing relevant to this event.Complaint not confirmed.No problems found.The tubing type is unknown.The returned ar-6480 was function tested with lab tubing set at varying pressures with no problems.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 or by the end user disconnecting and reconnecting the tubing from the pump or spiking the saline bags in the incorrect order.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.The instructions for use for both the pump and tubing sets clearly warn the user of the consequences of not following the instructions for use.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 (preoperative) 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 the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was originally reported that the event happened during surgery.Performed procedure was an arthroscopy of the upper ankle joint.The pump was running with a pressure of 35 but the lower leg was continuously flooded with water.Follow-up investigation: compartment syndrome was the outcome.The surgeon had to make an additional cut to get the water out of the lower leg.Surgery was aborted.No further info available.

• 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: 5519223
• MDR Text Key: 40937341
• Report Number: 1220246-2016-00129
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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
• Patient Outcome(s): Other