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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; RADIOFREQUENCY GENERATOR
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BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; RADIOFREQUENCY GENERATOR Back to Search Results
Model Number RFP-100A
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
There was no patient impact or consequence.Baylis medical company inc.Has decided to report this event due to the procedural delay that occurred.Dhr review was completed and the device fulfilled all requirements prior to release.
 
Event or Problem Description
A 20-minute procedural delay was reported in a case where the baylis radiofrequency perforation generator produced an error and was unable to reboot.Another generator was used for the procedure.While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the procedural delay.
 
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Brand Name
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
Common Device Name
RADIOFREQUENCY GENERATOR
MDR Report Key12278842
Report Number9710452-2021-00038
Device Sequence Number11897779
Product Code GEI
UDI-Device Identifier00685447000969
UDI-Public(01)00685447000969
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K122278
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/05/2021
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
Operator of Device Health Professional
Device Model NumberRFP-100A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2021
Initial Report FDA Received Date08/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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