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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FA COBLATOR II CONTROLLER (120V) SAW, POWERED, AND ACCESSORIES

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ARTHROCARE CORP. FA COBLATOR II CONTROLLER (120V) SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 13546-01
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reference: (b)(4).
 
Event Description
It was reported that the controller was not getting any power after being plugged. It is unknown whether the event happened during surgery and if there was a patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameFA COBLATOR II CONTROLLER (120V)
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
holly topping
7000 west william cannon drive
austin
5123913905
MDR Report Key11338878
MDR Text Key232381941
Report Number3006524618-2021-00212
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13546-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
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? No
Type of Device Usage Unkown

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