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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP ARTHROSCOPE

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ARTHREX, INC. CWIII ARTHROSCOPY PUMP ARTHROSCOPE Back to Search Results
Model Number CWIII ARTHROSCOPY PUMP
Device Problem Pressure Problem (3012)
Patient Problem Swelling (2091)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/ is expected but has not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that there was a malfunction with the pump. Arthroscopy pump worked with a notable increased pressure despite normal pressure display. On 24-jan-2019 additional information obtained: water flow and function of the shaver was controlled before the surgery. According to the display it was always only 50mmhg pressure. During surgery shoulder became swollen within 10 minutes so the anesthesia sounded alarm and the surgery was aborted. A second surgery needs to be done. On 07-feb-2019 additional information obtained: there was massive swelling in soft tissues.
 
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Brand NameCWIII ARTHROSCOPY PUMP
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 Key8344364
MDR Text Key136295938
Report Number1220246-2019-00897
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K024291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCWIII ARTHROSCOPY PUMP
Device Catalogue NumberAR-6475
Device Lot NumberNB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2014
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: 02/15/2019 Patient Sequence Number: 1
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