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

Catalog Number AR-6480

Device Problems Display or Visual Feedback Problem (1184); Increase in Pressure (1491)

Patient Problem Pain (1994)

Event Date 11/03/2016

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.No device malfunction identified.The device was requested/is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.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.Device requested but not yet received.

Event Description

It was reported that a rotator cuff repair was performed on a (b)(6), average built male.After 5 minutes water sprayed into the surgeons face and it escaped through the side of the arthroscope.The pump worked as normal, the pressure displayed on the screen showed 40.The surgeon took out the arthroscope, water then splashed out of the shoulder and the pump started to unravel on high speed.The pump was shut off, electric was shut off and the system was re-started.When the surgeon started the procedure anew, the same problem described above occurred.The pressure inside the shoulder increased significantly without any indication on the display.The shoulder was so blown up at they must stop the surgery.They changed the entire tubings and then everything worked as normal.The patient was admitted to the observation unit for the night due to the immense pain in his shoulder.The patient is currently healing.The main pump tubing ar-6420 and patient extension tubing ar-6425 were used.No further surgery is planned, the patient is healing and the surgeon thinks he will be ok.

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 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.Complaint not confirmed.The original tubing sets (ar-6420 and ar-6425) that are not distributed or used in the u.S.Were not returned.The returned ar-6480 was inspected per arthrex standard inspection procedures and tested with u.S.Distributed tubing set at varying pressures.Then the outflow tubing was clamped off and as expected per the operation manual, the pump reported "over pressure" alarm.When the clamp was released, the pump returned to normal operation.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 additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that a rotator cuff repair was performed on a (b)(6), average built male.After 5 minutes water sprayed into the surgeons face and it escaped through the side of the arthroscope.The pump worked as normal, the pressure displayed on the screen showed 40.The surgeon took out the arthroscope, water then splashed out of the shoulder and the pump started to unravel on high speed.The pump was shut off, electric was shut off and the system was re-started.When the surgeon started the procedure anew, the same problem described above occurred.The pressure inside the shoulder increased significantly without any indication on the display.The shoulder was so blown up at they must stop the surgery.They changed the entire tubings and then everything worked as normal.The patient was admitted to the observation unit for the night due to the immense pain in his shoulder.The patient is currently healing.The main pump tubing ar-6420 and patient extension tubing ar-6425 were used.No further surgery is planned, the patient is healing and the surgeon thinks he will be ok.

• 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: 6140679
• MDR Text Key: 61300198
• Report Number: 1220246-2016-00537
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• 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: 01/12/2017

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: NX2404PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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