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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pleural Effusion (2010)

Event Date 04/14/2021

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. If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported during a shoulder scope procedure the ar-6480 dualwave pump was being used. The patient had a build up of fluid that looked to have infiltrated into the chest area and up the neck. The pump was running at a normal rate and had to be run on lavage a couple times through the case due to bleeding in the shoulder. The patient ended up needing a chest tube to drain the fluid and is now fine. The surgeon is unsure how it could have happened as this has never happened before and said that it does not make sense in how fluid could infiltrate the way it did without the patient having some sort of morbidity that they did not take into account. This pump had been used prior in the day with no issues at all.

• 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: 11761212
• MDR Text Key: 248547687
• Report Number: 1220246-2021-02989
• Device Sequence Number: 1
• Product Code: HRX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/03/2021 Patient Sequence Number: 1