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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN STANDARD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION LEVEEN STANDARD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
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.
 
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Brand Name
LEVEEN STANDARD
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16136917
MDR Text Key308464487
Report Number2124215-2022-56274
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
Report Date 01/11/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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