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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 Self-Activation or Keying (1557)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2023
Event Type  malfunction  
Event Description
On 06/12/2023, it was reported by a facility representative via sems that an ar-6480 pump goes straight to suction when the pump turns on.This was discovered during an unspecified time with no patient effect.
 
Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
 
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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 Key17336776
MDR Text Key319385706
Report Number1220246-2023-07188
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 Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2023
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 Number15087215
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/12/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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