STRAIGHTSHOT® 1899200RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169588110), received between May 7, 2018 and Jun 22, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE, THE HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573284 ↗
• MalfunctionJan 7, 2026Overheating of Device

  IT WAS REPORTED THAT THE M5 HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986940 ↗
• MalfunctionMay 2, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT CONTINUE TO RUN WITHOUT THE PEDAL AND THE MOTOR SOUNDS WEIRD. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21949413 ↗
• MalfunctionFeb 4, 2025Vibration; Noise, Audible; Physical Resistance/Sticking; Vibration; Noise, Audible; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO USE ON THE PATIENT, THE DEVICE WAS RUNNING ROUGH AND CHATTERING. TROUBLESHOOTING WAS PERFORMED BY MOVING THE HANDPIECE FORWARD, THEN IN REVERSE, AND OSCILLATING IT A FEW TIMES, WHICH STOPPED THE VIBRATION, AND THE CASE PROCEEDED. THE HANDPIECE WAS MAKING A FUNNY SOUND RATHER THAN VIBRATING, AND THE BLADE WASN'T OSCILLATING SMOOTHLY. DURING THE INTRA-OPERATIVE PROCEDURE, THE EVENT OCCURRED TWICE. AFTER TROUBLESHOOTING AND FIXING IT, THE HANDPIECE WAS USED AGAIN, BUT THERE WAS A SECOND OCCURRENCE AS WELL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301263 ↗
• MalfunctionJun 27, 2024Overheating of Device; Mechanical Jam; Noise, Audible; Overheating of Device; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT PRE-OP, THE M5 HANDPIECE MADE A HUMMING SOUND BUT THE BUR DID NOT TURN, HANDLE WAS HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624884 ↗
• MalfunctionJun 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVELY, DEVICE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545226 ↗
• MalfunctionMay 17, 2024Use of Device Problem; Vibration; Noise, Audible; Use of Device Problem; Vibration; Noise, Audible

  IT WAS REPORTED THAT THE M5 HANDPIECE WAS VIBRATING, UNUSUAL NOISE AND NON FUNCTIONAL. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342887 ↗
• MalfunctionMay 17, 2024Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT DURING TESTING M5 HANDPIECE MAKING AN UNUSAL SOUND WHEN IN USE, AND SHAKING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339314 ↗
• MalfunctionJan 11, 2024Vibration; Vibration

  IT WAS REPORTED THAT HANDPIECE WAS WOBBLING DURING INTRA-OPERATIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490662 ↗
• MalfunctionNov 1, 2023Vibration; Vibration

  A HEALTH CARE PROFESSIONAL REPORTED THAT, M5 HANDPIECE WAS VIBRATING OUT OF CONTROL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18045690 ↗
• MalfunctionAug 7, 2023Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED THAT, HANDPIECE WAS NOT OVERHEATING AND IT STOPPED WORKING AFTER THE BURR BROKE AND THE STEM GOT STUCK. HANDPIECE OVERHEATING OCCURRED AT MORE THAN 20 MINUTES. HANDPIECE WAS BEING RUN AT 30K SPEED IN DRILL MODE. ANOTHER HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467919 ↗
• MalfunctionJul 27, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, HANDPIECE OVERHEATED AS SOON AS IT WAS PLUGGED INTO CONSOLE AND GAVE ERROR CODE 15 WHICH SAID 'CHECK ACCESSORY, HANDPIECE STALLED' . THE DEVICE WAS BEING RUN AT 5000 RPM SPEED AND IRRIGATION WAS BEING USED, NORMAL FLOW RATE. PROCEDURE WAS COMPLETED WITH BACK PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403632 ↗
• MalfunctionJun 30, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT M5 HANDPIECE WAS DEFECTIVE. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, THAT THE DEVICE HAD HEATING ISSUE DURING PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237197 ↗
• MalfunctionMay 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE DEVICE WAS OVERHEATING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017358 ↗
• MalfunctionMay 11, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE HAD LAGS AND THEN DOES NOT SHUT OFF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910111 ↗
• MalfunctionMay 1, 2023Vibration; Vibration

  IT WAS REPORTED THAT M5 HANDPIECE HAD TOO MUCH VIBRATION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850169 ↗
• MalfunctionJan 23, 2023Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT THE M5 MICRODEBRIDER CHATTERS AND MAKING STRANGE NOISE AT HIGH SPEED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223852 ↗
• MalfunctionOct 17, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE, HANDPIECE HEATS UP WHEN IN USE. HAPPENS AT 5000 RPM OSCILLATING WHILE USING RAD 60 BLADE. THERE WAS NO KNOWN PATIENT IMPACT. ADDITIONAL INFORMATION INDICATED THAT CUSTOMER REFUSED THE DEVICE RETURN, WHEN TESTED IN BIOMED, DID NOT HEAT UP. THE PROCEDURE WAS COMPLETED WITH MEDTRONIC REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616233 ↗
• MalfunctionSep 8, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE THE HUB OF THE BUR WAS MELTED AND STUCK IN THE HANDPIECE. THE HANDPIECE OVERHEATED AND BUR MELTED UPON LESS THAN 1 MINUTE THEN STOPPED. DEVICE RUN AT 30K FORWARD MODE. STANDARD FLOW IRRIGATION WAS USED. BUR WAS UNABLE TO REMOVE FROM HANDPIECE. PROCEDURE PERFORMED WAS ESS. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378112 ↗
• MalfunctionJul 19, 2022Vibration; Vibration

  HCP REPORTED THAT DURING INTRA-OP STAGE, THE DEVICE SHAKES WHEN IN USE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15057334 ↗
• MalfunctionApr 27, 2022Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE GETS TOO HOT AND DISPLAYS MESSAGE ON THE SCREEN: HANDPIECE STALLED. EVENT OCCURRED INTRA-OP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223877 ↗
• MalfunctionApr 4, 2022Vibration; Noise, Audible; Vibration; Noise, Audible

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE IS MAKING GRINDING NOISE AND VIBRATED EXCESSIVELY AT TIMES WHEN IN USE. THERE IS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13999664 ↗
• MalfunctionJan 18, 2022Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280390 ↗
• MalfunctionNov 16, 2021Display or Visual Feedback Problem; Mechanical Problem; Overheating of Device; Display or Visual Feedback Problem; Mechanical Problem; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE GETS TOO HOT AND DISPLAYS MESSAGE ON THE SCREEN: HANDPIECE STALLED. EVENT OCCURRED INTRA-OP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817970 ↗
• MalfunctionAug 18, 2021Excessive Heating; Excessive Heating

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE IS OVERHEATING. THERE IS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS REPORTED THAT THE HANDPIECE OVERHEATED IMMEDIATELY IN TESTING DURING STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E