DeRoyal 89-6015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756654531), received between Jun 15, 2018 and Jul 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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. 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.

• MalfunctionJul 20, 2018Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  DURING CLOSING COUNT OF A TISSUE REMOVAL AND NEEDLE BIOPSY, IT WAS NOTICED THAT TWO NEEDLES WERE STUCK TOGETHER, WHICH CAUSED THE COUNT TO BE OVER BY ONE NEEDLE. AN X-RAY WAS TAKEN TO CONFIRM THAT THERE WAS NO FOREIGN BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707917 ↗
• MalfunctionJun 15, 2018Sticking; Defective Component

  DURING CLOSING COUNT IT WAS NOTICED THAT THERE WAS 2 NEEDLES STUCK TOGETHER CAUSING THE COUNT TO BE OVER BY 1 NEEDLE. WE COUNTED ALL SHARPS AND SPONGES BEFORE THE SURGERY. IT WAS A MANUFACTURING DEFECT THAT CAUSED THE INCORRECT COUNT. IT COULD NOT BE NOTICED UNTIL THE NEEDLE WAS ABOUT TO BE LOADED ON NEEDLE DRIVER. AN X-RAY WAS TAKEN BY DOCTORS AND CONFIRMED THAT THE X-RAY WAS NEGATIVE FOR RETAINED FOREIGN BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605132 ↗