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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE AND ACCESSORIES
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ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE AND ACCESSORIES Back to Search Results
Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Problem Decrease in Pressure (1490)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure is user error; however, due to the device not being returned, we are unable to confirm the reported event.
 
Event Description
On 06/10/2022, it was reported by a sales representative via sems that a ar-6480 dw pump is outputting low pressure even though it is set at 60.This occurred during an unknown case, with no patient effect reported.
 
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Brand Name
DW ARTHROSCOPY FLUID MANAGEMENT DEV
Type of Device
ARTHROSCOPE AND ACCESSORIES
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
emily shafer
8009337001
MDR Report Key18453477
MDR Text Key332540986
Report Number1220246-2024-00143
Device Sequence Number1
Product Code HRX
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 01/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
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
Was Device Available for Evaluation? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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