RemB 6400009000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613154938230), received between Jul 24, 2018 and Jul 26, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE HANDPIECE VIBRATED WHILE IN SAFE MODE DURING A CASE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836950 ↗
• MalfunctionJun 4, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DEVICE ACTIVATED WHILE ON SAFETY AT THE USER FACILITY DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462209 ↗
• MalfunctionApr 12, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE USER FACILITY REPORTED THAT THE DEVICE WAS STUCK IN RUN IN THE OPERATING ROOM. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097281 ↗
• MalfunctionDec 14, 2023Fail-Safe Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Fail-Safe Did Not Operate

  THE USER FACILITY REPORTED THAT THE DEVICE WAS STUCK IN THE RUN POSITION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332022 ↗
• MalfunctionOct 2, 2023Unintended Power Up; Fail-Safe Did Not Operate; Unintended Power Up; Fail-Safe Did Not Operate

  THE USER FACILITY REPORTED THAT THE DEVICE RAN WITH THE SAFETY ON. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856184 ↗
• MalfunctionJul 13, 2023Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RAN ON ITS OWN DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320312 ↗
• MalfunctionJun 8, 2022Fail-Safe Problem; Fail-Safe Problem

  THE USER FACILITY REPORTED THAT THE DEVICE WAS NOT TURNING OFF IN SAFE DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14637998 ↗
• MalfunctionFeb 22, 2022Fail-Safe Problem; Fail-Safe Problem

  THE USER FACILITY REPORTED THAT THE DEVICE RAN IN SAFE MODE DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579865 ↗
• MalfunctionJul 13, 2021Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS ACTIVATING IN SAFE DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159026 ↗
• MalfunctionNov 6, 2020Device Remains Activated; Device Remains Activated

  THE USER FACILITY REPORTED THAT THE DEVICE RAN WHILE IN SAFE MODE DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10804939 ↗
• MalfunctionFeb 5, 2020Device Remains Activated; Fail-Safe Problem; Device Remains Activated; Fail-Safe Problem

  THE USER FACILITY REPORTED THAT THE DEVICE RAN IN SAFE MODE DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9670637 ↗
• MalfunctionJul 24, 2018Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. TWO EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7715534 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH; 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7715249 ↗