• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE Back to Search Results
Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)
Patient Problem Swelling/ Edema (4577)
Event Date 05/05/2021
Event Type  malfunction  
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 that during a knee arthroscopy surgery the device ran to fast and build up a lot of pressure. This failure remained after the tubing was changed. The lower leg was filled with fluid and became hard due to the swelling. The patient had to be hospitalized after the surgery. The surgery was finished successfully with the same device. It was not necessary to switch the surgical technique or do a second surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDW ARTHROSCOPY FLUID MANAGEMENT DEV
Type of DeviceARTHROSCOPE
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 Key11872122
MDR Text Key252314505
Report Number1220246-2021-03141
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Device Lot Number10014639
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/24/2021 Patient Sequence Number: 1
-
-