NA 5450800307Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613252026679), received between Aug 13, 2019 and Apr 22, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Melted

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MELTED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954407 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985872 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE TIP BROKE IN TWO. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AS THE DEVICE COULD NOT BE USED. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES, OR NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443787 ↗
• 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 15021552 ↗
• MalfunctionJun 9, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP COVER/SLEEVE OF THE TIP WAS DEFORMED/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 14643066 ↗
• MalfunctionNov 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP WAS DAMAGED AND STOPPED WORKING DURING A HEPATIC SEGMENTECTOMY SURGICAL PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780263 ↗
• MalfunctionAug 16, 2021Fracture; Fracture

  IT WAS REPORTED, THAT DURING TESTING. THE TIP OF THE DEVICE BROKE WITHOUT EXTERNAL INFLUENCE. IT WAS FURTHER REPORTED, THAT THIS EVENT DID NOT OCCUR, DURING A SURGICAL PROCEDURE. AND THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328444 ↗
• MalfunctionNov 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN ON OPENING THE DEVICE PACKAGING. 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 10862742 ↗
• MalfunctionNov 18, 2020Excessive Heating; 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 10862734 ↗
• MalfunctionOct 21, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP WAS DEFORMED DUE TO EXCESSIVE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10713022 ↗
• MalfunctionOct 20, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP WAS DEFORMED DUE TO EXCESSIVE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10707887 ↗
• MalfunctionJun 17, 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 10162412 ↗
• MalfunctionMay 1, 2020Melted; Melted

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT SONOPET 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 Consequences Or Impact To Patient

  MAUDE report 10019014 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL TUMOR SURGERY THE DURA WAS INJURED. IT WAS FURTHER REPORTED THAT THERE WERE NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Abrasion

  MAUDE report 9601425 ↗
• MalfunctionSep 3, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP BROKE AT THE CUTTING END DURING A MENINGIOMA TUMOR SURGERY. IT WAS ALSO REPORTED THAT THE SURGEON WAS ABLE TO SAFELY REMOVE THE BROKEN PIECE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956656 ↗
• MalfunctionAug 13, 2019Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A NEURO TUMOR REMOVAL PROCEDURE THE IRRIGATION SLEEVE OF THE STRAIGHT TIP MELTED. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE.IT WAS SUBSEQUENTLY REPORTED THAT THE TIP ALSO BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888455 ↗