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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FA RF8000E,120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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ARTHROCARE CORP. FA RF8000E,120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 13546-01
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Event Description
It was reported that the device has a surgical shortage.No case reported.
 
Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.Visual inspection of the returned controller found no deficiencies.Functional evaluation revealed that the controller functioned as intended.All ablation and coagulation output voltages fell within specified ranges, however the flow valve and led was stuck on.The complaint was not verified and the root cause was unable to be determined since the device functioned as intended.
 
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Brand Name
FA RF8000E,120V
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key7564041
MDR Text Key110050586
Report Number3006524618-2018-00295
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K030108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/03/2018
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 Catalogue Number13546-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/03/2018
Supplement Dates Manufacturer Received08/01/2018
Supplement Dates FDA Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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