MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	RFP-100A
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bmc rf puncture generator was selected for use during a portal vein re-cannulization procedure, and once connected to the connector cables and a non-boston scientific wire the console gave the alert a029.The grounding pad was connected and no error was given.However, once the devices were connected to the generator along with the connector cable, again the error was displayed.To troubleshoot, the bmc generator was turned off and back on after the message.Also, the connector cables for two non-boston scientific wires were unplugged and plugged back in and the error persisted.No patient complications were reported.The procedure was aborted.The device is not expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Correction to the initial mdr: the fields d2a (common device name), (initial reporter title) and (bsc aware date) were updated.Thus, this supplemental report is being filed.T was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a bmc rf puncture generator was selected for use during a portal vein re-cannilazation procedure, and once connected to the connector cables and a non-boston scientific wire the console gave the alert a029.The grounding pad was connected and no error was given.However, once the devices were connected to the generator along with the connector cable, again the error was displayed.To troubleshoot, the bmc generator was turned off and back on after the message.Also, the connector cables for two non-boston scientific wires were unplugged and plugged back in and the error persisted.No patient complications were reported.The procedure was aborted.The device is not expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17343218
• Report Number: 2124215-2023-37619
• Device Sequence Number: 12486155
• Product Code: GEI
• UDI-Device Identifier: 00685447000969
• UDI-Public: 00685447000969
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Number: RFP-100A
• Device Lot Number: 200117-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown