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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was not completed due to this event.A rf3000 radiofrequency generator was selected for use.During the procedure, the generator did not work after turning on.The procedure was not completed due to the event.There were no patient complications or additional intervention, and the patient status is stable.
 
Event Description
It was reported that the procedure was not completed due to this event.A rf3000 radiofrequency generator was selected for use.During the procedure, the generator did not work after turning on.The procedure was not completed due to the event.There were no patient complications or additional intervention, and the patient status is stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned and serviced.The device failed the post test with a h07 fault.The rf board was replaced with a good board and the device passed the post testing.This unit is to be scrapped.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15887997
MDR Text Key307565387
Report Number2124215-2022-47680
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
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 Number0406210310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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