MAUDE Adverse Event Report: CONMED CORPORATION 24K IRRIGATION CONSOLE; ARTHROSCOPIC IRRIGATION PUMP

Catalog Number 24K

Device Problem Increase in Pressure (1491)

Patient Problems Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation found that the motor was noisy, loud and needed to be upgraded.The eccentric cam was loose at the shuttle valve, tips connector was loose, and the unit failed to calibrate.Additionally, the unit was overdue for preventative maintenance.The servicing documents from the service history record have been reviewed and no data was found.A device history record was not reviewed since the device has been in the field for more than 12 months.At the time of this complaint, the device was approximately seven years and ten months of age without any history or preventative maintenance.A two-year review of complaint history revealed there has been 4 complaints regarding 4 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: that regular and proper maintenance of the equipment is the best way to protect your investment.It is essential to have your equipment serviced as scheduled to retain its' optimum performance and reliability, which will reward you with safer, less problematic product performance over time.The 24k irrigation system console and accessories shall be returned every 12 months for servicing.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported the 24k irrigation console needed calibration and that it was not working properly.The pump kept running although the button was pushed to stop it.This occurred mid surgery during a knee arthroscopy on (b)(6) 2019.It over-pressurized the joint, causing excessive bruising from the patient's knee to the groin.The console did not alarm, and the surgical staff was familiar with the device and tubing.There was a reported surgical delay although a time was not given.This report is being raised based on patient injury.

• Brand Name: 24K IRRIGATION CONSOLE
• Type of Device: ARTHROSCOPIC IRRIGATION PUMP
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8268343
• MDR Text Key: 133775148
• Report Number: 1017294-2019-00005
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2011
• 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