MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE STIMULONG SONO II NANOLINE®; STIMULONG SONO II NANOLINE®_ANESTHESIA CONDUCTION KIT

Model Number	03115137EB
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) complaint took place in germany.Two lot numbers had complaints (assignment under 2.3f, 2.3i, 2.3j): lot: 1517 manufacturing date: 2023-12-06/ expiry date: 2028-1 2-05.Lot: 1544 manufacturing date: 2024-06-19/ expiry date: 2029-06-18.This initial report summarises all the test results that were possible at the time of the review.Based on clinical assessment and risk assessment this 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
(b)(4) complaint took place in germany.Original text german: draht gar nicht vorschiebbar, hängt in der katheterschnecke fest.Draht ist die verbindung zum stimulierbaren katheter.Translation into english: wire cannot be advanced at all, is stuck in the catheter screw.The wire is the connection to the stimulable catheter.

• Brand Name: STIMULONG SONO II NANOLINE®
• Common Device Name: STIMULONG SONO II NANOLINE®_ANESTHESIA CONDUCTION KIT
• 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: 20734153
• Report Number: 9611612-2024-00028
• Device Sequence Number: 8989170
• Product Code: CAZ
• UDI-Device Identifier: 04048223117095
• UDI-Public: 04048223117095
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 03115137EB
• Device Catalogue Number: 521187-32C
• Device Lot Number: 1517, (1544)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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