NA 5100010272Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540352781), received between Aug 8, 2019 and Aug 8, 2019 — classified as 1 malfunction.

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

• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY AN IRRIGATING ATTACHMENT WAS DROPPED ON THE FLOOR. THE ITEM WAS PICKED UP AND PLACED ON A TRAY OF IDENTICAL EQUIPMENT AND THE CASE PROCEEDED AFTER A NURSE VERIFIED THE INTEGRITY OF THE EQUIPMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A FEW HOURS AFTER SURGERY THE CENTRAL STERILE DEPARTMENT NOTED A BROKEN TIP ON ONE OF THE IRRIGATING ATTACHMENTS PRESENT DURING THE CASE. THE DOCTORS FOR THE CASE INFORMED THE PATIENT OF THE BROKEN TIP. FOLLOW-UP X-RAYS ON THE PATIENT DID NOT DETECT ANY DEVICE FRAGMENTS IN THE PATIENT. NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8877071 ↗