ULTRAPOWER 00702114100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854003459), received between Dec 27, 2022 and Dec 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00702114100, 1.5MM ULTRAPOWER BUR, WIRE PASS, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿ULTRAPOWER BUR WIRE PASS WAS BROKEN DURING BRAIN SURGERY TO OPEN A BONE HOLE IN THE SKULL.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED USING ¿SOMETHING LIKE FORCEPS¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE ¿BACKUP PRODUCT¿. THE PATIENT'S CURRENT STATUS WAS REPORTED AS "THERE IS NO PARTICULAR PROBLEM WITH THE PATIENT". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053045 ↗