Sterile Disposable Endocavity Needle Guide 5145Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841912101627), received between Mar 22, 2017 and Mar 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  AN INCIDENT OCCURED WITH DEVICE REF (B)(4), LOT# 72335, EXP 06.2021, ON (B)(6) 2017. INCIDENT CONCERNS ESCAPING OF THE METAL CANNULA FROM ITS GUIDE DURING THE DEVICE USE FOR PROSTATE BIOPSY ON A (B)(6) YEAR OLD PATIENT. DEVICE WAS USED AND NO FURTHER CONSEQUENCE HAVE BEEN NOTIFIED, NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424035 ↗