SONOTAP II 1265-3E080Recalls & reported problems
Pajunk GmbH Medizintechnologie · 1265-3E080 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223116241), received between Jul 10, 2024 and Jul 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2024Break; Material Separation; Break; Material Separation
IRN# (B)(4). LORS DE LA RÉALISATION D'UN BLOC TRÈS PROFOND, IL A ÉTÉ CONSTATÉ QUE L'AIGUILLE S'EST CASSÉE EN SON EMBOUT LORS D'UN LÉGER CHANGEMENT DE DIRECTION AFIN D'AFFINER L'IMAGE. LE MÉDECIN A RÉUSSI À RETENIR L'AIGUILLE AFIN D'ÉVITER LA PERTE IN SITU CHEZ LE PATIENT DE 21 ANS. IL N'Y A PAS EU DE CONSÉQUENCE CLINIQUE MAIS CET INCIDENT A PRÉSENTÉ LE RISQUE DE LA PERTE IN SITU. IL S'AGIT DU PREMIER INCIDENT DE CE TYPE. DURING THE PERFORMANCE OF A VERY DEEP BLOCK, THE NEEDLE WAS FOUND TO HAVE BROKEN OFF AT ITS TIP DURING A SLIGHT CHANGE OF DIRECTION TO REFINE THE IMAGE. THE DOCTOR MANAGED TO RETAIN THE NEEDLE TO AVOID IN SITU LOSS IN THE 21-YEAR-OLD PATIENT. THERE WERE NO CLINICAL CONSEQUENCES, BUT THIS INCIDENT PRESENTED THE RISK OF IN SITU LOSS. THIS IS THE FIRST INCIDENT OF ITS KIND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711739 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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