NA 6003-011-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540246028), received between Feb 16, 2017 and Apr 22, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Disassembly” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  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: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954346 ↗
• MalfunctionNov 27, 2019Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE CUSTOMER OBSERVED THAT A RUBBER GASKET WAS MISSING ON THE DEVICE WHEN INSPECTED BEFORE A PROCEDURE. THE GASKET BEING DETACHED POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9386332 ↗
• MalfunctionAug 30, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE DEVICE WAS OBSERVED TO BE BROKEN PRIOR TO RE-PROCESSING; THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 8949769 ↗
• MalfunctionJan 15, 2019Break; Break

  IT WAS REPORTED THAT AT THE USER FACILITY THE TIP BROKE OFF. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8250716 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED DURING A SERVICE EVALUATION THAT THE TIP OF THE DEVICE WAS FOUND BROKEN OFF. THERE WAS NO PATIENT IMPACT, MEDICAL INTERVENTION, OR PROCEDURAL DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156823 ↗
• MalfunctionApr 21, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE TIP 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 6510579 ↗
• MalfunctionApr 13, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE TIP OF THE DEVICE WAS FOUND TO BE BROKEN OFF. ALTHOUGH REQUESTED, THE USER FACILITY WAS UNABLE TO PROVIDE ANY FURTHER DETAILS SURROUNDING THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6491185 ↗
• MalfunctionApr 3, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE TIP 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 6452700 ↗
• MalfunctionMar 3, 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 6375757 ↗
• MalfunctionFeb 16, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE LED COVER FELL OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6335107 ↗