SONOPLEX® II
Received Nov 11, 2025 · Event occurred Oct 20, 2025
Report 9611612-2025-00046 · MDR key 23521676
Device
Generic name
Sonoplex® Ii
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
001285-74
Lot number
1585
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
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.
Description of Event or Problem
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.