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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 03/09/2021
Event Type  malfunction  
Event Description
It was reported insufficient roll-off occurred.A radiofrequency ablation procedure was being performed.A 3cm electrode was used with an rf3000 generator to ablate the tissue.While using the devices roll-off was unable to be achieved.The physician attempted a new 3.5cm electrode, but had the same results.Therefore, the procedure was ended.There were no patient complications that were reported.
 
Manufacturer Narrative
Corrected h8: usage of device from initial use to reuse.
 
Event Description
It was reported insufficient roll-off occurred.A radiofrequency ablation procedure was being performed.A 3cm electrode was used with an rf3000 generator to ablate the tissue.While using the devices roll-off was unable to be achieved.The physician attempted a new 3.5cm electrode, but had the same results.Therefore, the procedure was ended.There were no patient complications that were reported.
 
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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
MDR Report Key11607380
MDR Text Key243547604
Report Number2134265-2021-03876
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K000241
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/06/2021
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 Model Number36725
Device Catalogue Number36725
Device Lot Number0121814006
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/09/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received04/06/2021
Patient Sequence Number1
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