NA 5450800309Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252026693), received between Apr 15, 2020 and Feb 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TUMOR REMOVAL CASE, THE TIP BROKE 10 MINS INTO USE. THE SECOND TIP USED WITH THE SAME HANDPIECE ALSO BROKE ABOUT 10 MINUTES INTO USE. A THIRD TIP AND A NEW HANDPIECE WAS RETRIEVED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE FOLLOWING DAY THE ACCOUNT WAS TESTING THE HANDPIECE IN USE DURING THE TIP BREAKS AND WHEN A TIP OF A DIFFERENT LOT NUMBER (ON METAL) WAS TESTED IT CRACKED IN A SIMILAR SPOT. THIS REPORT IS FOR THE SECOND TIP THAT BROKE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410463 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TUMOR REMOVAL CASE, THE TIP BROKE 10 MINS INTO USE. THE SECOND TIP USED WITH THE SAME HANDPIECE ALSO BROKE ABOUT 10 MINUTES INTO USE. A THIRD TIP AND A NEW HANDPIECE WAS RETRIEVED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE FOLLOWING DAY THE ACCOUNT WAS TESTING THE HANDPIECE IN USE DURING THE TIP BREAKS AND WHEN A TIP OF A DIFFERENT LOT NUMBER (ON METAL) WAS TESTED IT CRACKED IN A SIMILAR SPOT. THIS REPORT IS FOR THE FIRST TIP BROKE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410461 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TUMOR REMOVAL CASE, THE TIP BROKE 10 MINS INTO USE. THE SECOND TIP USED WITH THE SAME HANDPIECE ALSO BROKE ABOUT 10 MINUTES INTO USE. A THIRD TIP AND A NEW HANDPIECE WAS RETRIEVED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE FOLLOWING DAY THE ACCOUNT WAS TESTING THE HANDPIECE IN USE DURING THE TIP BREAKS AND WHEN A TIP OF A DIFFERENT LOT NUMBER (ON METAL) WAS TESTED IT CRACKED IN A SIMILAR SPOT. THIS REPORT IS FOR THE TIP THAT BROKE ON THE SECOND DAY DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410459 ↗
• MalfunctionJul 14, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO TIPS OF TWO DEVICES OVERHEATED AND MELTED THE SLEEVE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE INSTANCES OF THE REPORTED OVERHEATING AND MELTING SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021314 ↗
• MalfunctionJul 1, 2021Fracture; Fracture

  IT WAS REPORTED, THAT PRIOR TO A SURGICAL PROCEDURE. THE TIP/SLEEVE WAS OBSERVED, TO BE BROKEN. IT WAS ALSO REPORTED, THAT THIS EVENT DID NOT OCCUR, DURING A SURGICAL PROCEDURE. AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099731 ↗
• MalfunctionOct 30, 2020Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP SLEEVE MELTED. 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 10763919 ↗
• MalfunctionOct 30, 2020Overheating of Device; Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP SLEEVE MELTED. 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 10763904 ↗
• MalfunctionApr 15, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE MELTED DUE TO HEAT. 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 Consequences Or Impact To Patient

  MAUDE report 9962071 ↗