MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Edema (1820)

Event Date 12/11/2020

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 the ar-6480 dualwave pump has had a few occurrences where the pump does not regulate fluid and continues to push fluid into the joint.The latest occurrence happened during a knee arthroscopy and proceeded to blow up the knee joint.The surgeon was not happy.Another tubing set was brought in and used with the pump and the issue occurred again.Additional information received on 12/23/2020: the facility stated that manual pressure was applied to the affected area to remove the excess fluid.The patient was not kept overnight, and was discharged without a prolonged recovery.The part and lot numbers of the pump tubing used was provided.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• 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 ; 8009337001
• MDR Report Key: 11147090
• MDR Text Key: 226051659
• Report Number: 1220246-2021-02464
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other