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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE
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ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE Back to Search Results
Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Problems Device Emits Odor (1425); Power Problem (3010)
Patient Problem Insufficient Information (4580)
Event Date 07/27/2022
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
On 07/27/2022, it was reported by a facility representative via sems that an ar-6480 dw arthroscopy fluid management device had a burning smell and no power.This was discovered during an unspecified time with no case involvement.
 
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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 Key15223950
MDR Text Key305065776
Report Number1220246-2022-05370
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00888867039377
UDI-Public00888867039377
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Device Lot Number22104014
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/27/2022
Initial Date FDA Received08/15/2022
Date Device Manufactured06/28/2021
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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