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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RF 3000 RADIO FREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION RF 3000 RADIO FREQUENCY 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 12/01/2021
Event Type  malfunction  
Event Description
It was reported insufficient roll off occurred.The patient underwent a radiofrequency ablation procedure on their kidney.An rf generator 3000 and an rf probe were used.Computed tomography (ct) imaging at this time showed everything appeared normal.At the 3 month follow up appointment it was observed that the tumor was not ablated.No patient complications were reported.
 
Manufacturer Narrative
Date of event: this date is unknown and was therefore estimated.
 
Manufacturer Narrative
B3 date of event: this date is unknown and was therefore estimated.B5 describe event or problem & e1 initial reporter title, initial reporter first name & initial reporter last name: updated.
 
Event Description
It was reported insufficient roll off occurred.The patient underwent a radiofrequency ablation procedure on their kidney.An rf generator 3000 and an rf probe were used.Computed tomography (ct) imaging at this time showed everything appeared normal.At the 3 month follow up appointment it was observed that the tumor was not ablated.No patient complications were reported.It was further reported that roll-off, which indicates the clinical endpoint, was achieved at the time of the index procedure.During the index procedure, a ct scan is used for placement of the probe only, they do not perform a ct with contrast to confirm ablation.The ablation is confirmed at the 3 month follow up using a ct scan with contrast, which in this case revealed the tumor was not ablated.
 
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Brand Name
RF 3000 RADIO FREQUENCY 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13075228
MDR Text Key282715240
Report Number2134265-2021-16159
Device Sequence Number1
Product Code GEI
UDI-Device Identifier08714729375463
UDI-Public08714729375463
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K000241
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 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
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 Number0121814006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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