MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOPLEX® II

Catalog Number	001285-74
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Irn# (b)(4) incident occurred in belgium.Tentitive translation: while repositioning the needle during local anesthesia, the needle broke off inside the patient; fortunately, a small piece was visible and the doctor was able to remove the needle completely.
Additional Manufacturer Narrative
Irn# (b)(4) investigation is ongoing.Final evaluation can be found in following report.
Event or Problem Description
Irn# (b)(4).Incident occurred in belgium.Tentitive translation: while repositioning the needle during local anesthesia, the needle broke off inside the patient; fortunately, a small piece was visible and the doctor was able to remove the needle completely.
Additional Manufacturer Narrative
Irn#(b)(4).Fu 12/23/2025: the device was evaluated and the investigation results described and the imdrf codes updated.Furthermore, the udi was updated.This case is considered as closed.If further information becomes available an update will be sent to the agency.

• Brand Name: SONOPLEX® II
• Common Device Name: SONOPLEX® II
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 23521676
• Report Number: 9611612-2025-00046
• Device Sequence Number: 15921970
• Product Code: BSP
• UDI-Device Identifier: 04048223131008
• UDI-Public: 04048223131008
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K243682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Device Catalogue Number: 001285-74
• Device Lot Number: 1585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown