MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE

Model Number CWIII ARTHROSCOPY PUMP

Device Problems Defective Component (2292); Pressure Problem (3012)

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

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that due to obviously defective control (pressure sensor) the device generated a maximum pressure.The pressure could no longer be reduced, so that the treatment with this device had to be stopped immediately.According to the customer, there was a risk that the joint capsule would be injured.No further information received.

Manufacturer Narrative

Complaint not confirmed.During device functioning, the returned ar-6475 arthroscopy pump device was tested under normal use conditions to see if the issue reported could be reproduced.An ar-6410 tubing was assembled to the device.The pump was powered on and no error message and/or audible alarm was triggered.Further review of components, showed no issues with the latch door or tubing connector.The results of the clamp test confirmed the pump did alarm and provide an error as intended/expected.Among the most common causes for this type of occurrence, are unplugging and plugging the pressure line connector into the arthroscopy pump, creating a pressure decay on the pump or spiking bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.These conditions can trigger the alarm for pressure fault.

• Brand Name: CWIII ARTHROSCOPY PUMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9427626
• MDR Text Key: 169610804
• Report Number: 1220246-2019-01458
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (y/n): N
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 11/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other