NA 6002-005-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540350176), received between Feb 22, 2017 and Apr 28, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Disassembly” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. 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 11738764 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED THAT DURING A THE SERVICE EVALUATION PROCESS AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY COMPARTMENT BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130636 ↗
• MalfunctionJun 26, 2018Imprecision; Imprecision

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE DEVICE WAS NOT ACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7637524 ↗
• MalfunctionJun 29, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE A SCREW FELL OUT OF THE DEVICE ON THE SCRUB TABLE. THERE WERE NO ADVERSE CONSEQUENCES OR PROCEDURAL DELAYS AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6676285 ↗
• MalfunctionMar 14, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE BLACK LED COVER OF THE DEVICE WAS FOUND TO BE BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THIS EVENT BY THE USER FACILITY.

  Patient problems: No Patient Involvement

  MAUDE report 6404774 ↗
• MalfunctionFeb 22, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE POST WAS FOUND TO BE LOOSE, WHICH COULD CAUSE INACCURACY. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348628 ↗