NA 6000-006-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540245045), received between Nov 21, 2017 and Jul 11, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BATTERY WAS LEAKING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING RECEIPT AT THE FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726283 ↗
• MalfunctionApr 13, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106632 ↗
• MalfunctionMar 25, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902065 ↗
• MalfunctionJan 31, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397856 ↗
• MalfunctionDec 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910289 ↗
• MalfunctionOct 1, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING BEFORE A MEDICAL PROCEDURE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562669 ↗
• MalfunctionSep 27, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING BEFORE A MEDICAL PROCEDURE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532544 ↗
• MalfunctionDec 1, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10930075 ↗
• MalfunctionOct 9, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORT BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656961 ↗
• MalfunctionOct 9, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORT BY THE CUSTOMER THAT THEY FOUND DEBRIS IN THE STERILE PACKAGING PRIOR TO A PROCEDURE.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10656946 ↗
• MalfunctionDec 28, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE USER FACILITY A LEAK WAS FOUND IN THE BATTERY. THE BATTERY IS CONTAINED IN THE HAND PIECE AND COULD NOT LEAK ONTO THE PATIENT DURING A PROCEDURE, BUT THE LEAK COULD CAUSE THE BATTERY TO BECOME NON FUNCTIONAL DURING A PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150727 ↗
• MalfunctionDec 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT RECEIPT AT THE USER FACILITY A FOREIGN PARTICLE WAS FOUND IN THE STERILE PACKAGING OF THE INSTRUMENTS BATTERY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138500 ↗
• MalfunctionNov 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AT INSPECTION AT THE USER FACILITY A FOREIGN PARTICLE WAS FOUND IN THE STERILE PACKAGING OF THE INSTRUMENTS BATTERY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048122 ↗