OWL DTR-018/54/5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00825114004597), received between Dec 24, 2020 and Dec 28, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2020Material Separation

  IT WAS REPORTED TO THE MANUFACTURER THAT AFTER SUCCESSFULLY PERFORMING 2 LESIONS FOR THE SUPERO-MEDIAL GENICULAR NERVE, UPON RETRACTING THE CANNULA, A SMALL PIECE ABOUT 1-2 MM FROM THE DISTAL PART OF ONE OF THE 3 TINES WAS MISSING. UNDER FLUOROSCOPIC IMAGING, A TINY METALLIC POINT WAS OBSERVED NEAR THE SITE OF LESIONING. SUBSEQUENTLY, THE PATIENT WAS INFORMED AND AGREED NOT TO REMOVE IT. THE PROCEDURE WENT ON WITH A NEW CANNULA FOR THE LAST LESION, THE INFERO-MEDIAL GENICULAR NERVE WITHOUT ISSUE. IT IS EXPECTED THAT THE DEVICE WILL BE RETURNED TO THE MANUFACTURER ALONG WITH FLUOROSCOPIC IMAGING FOR FURTHER ANALYSIS AND TO CONTINUE THE INVESTIGATION. ON FLUOROSCOPIC IMAGING, PHYSICIAN COULD SEE A TINE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11087022 ↗
• MalfunctionDec 24, 2020Material Fragmentation; Material Separation; Material Fragmentation

  IT WAS REPORTED TO THE MANUFACTURER THAT AFTER SUCCESSFULLY PERFORMING 2 LESIONS FOR THE SUPERO-MEDIAL GENICULAR NERVE, UPON RETRACTING THE CANNULA, A SMALL PIECE ABOUT 1-2 MM FROM THE DISTAL PART OF ONE OF THE 3 TINES WAS MISSING. UNDER FLUOROSCOPIC IMAGING, A TINY METALLIC POINT WAS OBSERVED NEAR THE SITE OF LESIONING. SUBSEQUENTLY, THE PATIENT WAS INFORMED AND AGREED NOT TO REMOVE IT. THE PROCEDURE WENT ON WITH A NEW CANNULA FOR THE LAST LESION, THE INFERO-MEDIAL GENICULAR NERVE WITHOUT ISSUE. IT IS EXPECTED THAT THE DEVICE WILL BE RETURNED TO THE MANUFACTURER ALONG WITH FLUOROSCOPIC IMAGING FOR FURTHER ANALYSIS AND TO CONTINUE THE INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11072230 ↗