MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE RFTL; RFTL CANNULA/ PROBE, RADIOFREQUENCY LESION PRODUCT CODE: GXI

Model Number	001165-22C
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn# (b)(4).Initial batch review does not indicate any adverse conclusion.All parameters within specification.
Event or Problem Description
Irn# (b)(4).Event occurred in belgium: tentitive description of event: skin burns during procedure.
Additional Manufacturer Narrative
Event took place in belgium.This product analysis was carried out on the basis of all the information provided and the internal review at pajunk.Based on analysis, risk assessment, risk profile and clinical monitoringthis file is considered as closed.In case new information becomes available a follow up report will be sent to the agency.
Event or Problem Description
Irn# (b)(4).Event occurred in belgium.Tentitive description of event: skin burns during procedure.

• Brand Name: RFTL
• Common Device Name: RFTL CANNULA/ PROBE, RADIOFREQUENCY LESION PRODUCT CODE: GXI
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 20556646
• Report Number: 9611612-2024-00024
• Device Sequence Number: 15675012
• Product Code: GXI
• UDI-Device Identifier: 04048223050187
• UDI-Public: 04048223050187
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K060397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 001165-22C
• Device Catalogue Number: 001165-22C
• Device Lot Number: 1514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown