NA 6003-005-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540246004), received between Feb 14, 2017 and Mar 28, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Disassembly” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY HOUSING WAS BROKEN.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 8460382 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY HOUSING WAS BROKEN 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 8137722 ↗
• MalfunctionMar 6, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LED LENS OF THE DEVICE WAS IDENTIFIED AS BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS THE EVENT OCCURRED DURING THE EVALUATION PROCESS.

  Patient problems: No Patient Involvement

  MAUDE report 6379856 ↗
• MalfunctionFeb 16, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE PIN OF THE DEVICE WAS IDENTIFIED TO HAVE BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6335125 ↗
• MalfunctionFeb 14, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LENS OF THE DEVICE WAS IDENTIFIED TO BE BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6330556 ↗