NA 5450815100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252518396), received between Oct 19, 2018 and Apr 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING USE. 1 EVENT HAD PATIENT INVOLVEMENT WITH NO KNOWN IMPACT OR CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546064 ↗
• MalfunctionJan 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284714 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE BLADE BROKE. THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, AND THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984211 ↗