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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RF3000 RADIOFREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION RF3000 RADIOFREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 36725
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  malfunction  
Event Description
It was reported that insufficient roll off occurred.A rf3000 radiofrequency generator and an rf probe were selected for a radiofrequency ablation procedure.During the procedure, roll off occurred after 25min at 180 w.Ablation seemed to take longer than expected before reaching roll off, without the lesion having any particular characteristics.No patient complications were reported.
 
Manufacturer Narrative
Device evaluation by manufacturer: the device was returned and analyzed by the external manufacturer, stellartech.No problems were found when the device was analyzed and serviced.Performed power and impedance calibration.Checked and passed stress test.Incrementally powered unit from 0w to 200w at 25 and 100 load.No error occurred.
 
Event Description
It was reported that insufficient roll off occurred.A rf3000 radiofrequency generator and an rf probe were selected for a radiofrequency ablation procedure.During the procedure, roll off occurred after 25min at 180 w.Ablation seemed to take longer than expected before reaching roll off, without the lesion having any particular characteristics.No patient complications were reported.
 
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Brand Name
RF3000 RADIOFREQUENCY GENERATOR
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
STELLARTECH RESEARCH CORPORATION
560 cottonwood drive
milpitas CA 95035
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16136921
MDR Text Key308584230
Report Number2124215-2022-56272
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number36725
Device Catalogue Number36725
Device Lot Number0060515005
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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