NA 5450800312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252026723), received between Oct 9, 2020 and Dec 23, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF SLEEVE MELTED AND A PIECE HAD TO BE REMOVED FROM THE SURGICAL SITE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067427 ↗
• MalfunctionDec 18, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF SLEEVE MELTED AND A PIECE HAD TO BE REMOVED FROM THE SURGICAL SITE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11039441 ↗
• MalfunctionDec 18, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF SLEEVE MELTED AND A PIECE HAD TO BE REMOVED FROM THE SURGICAL SITE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11039419 ↗
• MalfunctionOct 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE AT THE TIP. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656984 ↗