DeRoyal 70-10770Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756194686), received between Apr 5, 2022 and Apr 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 5, 2022Break; Break

  HAVING BREAKAGE TROUBLE WITH THE ITEM 5-9043 NEEDLE WITHIN THIS TRAY. NO INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14015971 ↗
• MalfunctionApr 5, 2022Break; Break

  HAVING BREAKAGE TROUBLE WITH THE ITEM 5-9043 NEEDLE WITHIN THIS TRAY. WE HAD A 30G NEEDLE, WHICH WAS PART OF THE SAME LOT NUMBER, BREAK OFF IN A PATIENT'S BREAST. THIS PATIENT IS HAVING SURGERY FOR BREAST CANCER IN THE OPPOSITE BREAST, AND WILL HAVE THE NEEDLE REMOVED AT THAT TIME, IN THE OTHER BREAST. SHE HAD 2 BIOPSIES THE DAY THIS HAPPENED. SHE IS HAVING AN UNNECESSARY SURGERY DUE TO THE NEEDLE BREAKING OFF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14015477 ↗