NA 511.610Recalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 10886982237590), received between Nov 22, 2017 and Jan 23, 2026 — classified as 301 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (187 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE AIR OSCILLATOR DEVICE STOPPED WORKING DURING USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160841 ↗
• MalfunctionMay 29, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT THE AIR OSCILLATOR DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104516 ↗
• MalfunctionSep 27, 2022Unintended System Motion; Complete Loss of Power; Unintended System Motion; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE WAS LEAKY AND FAILED PRE-TEST FOR CHECK FOR UNINTENDED MOTION AND CHECK FOR AIR LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493766 ↗
• MalfunctionMar 26, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT THE AIR OSCILLATOR DEVICE WAS STOPPING. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) OF 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13920501 ↗
• MalfunctionMar 24, 2022Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED FROM (B)(6) THAT THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS LOCKED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873171 ↗
• MalfunctionMar 8, 2022Leak/Splash; Device Slipped; Vibration; Leak/Splash; Device Slipped; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING TESTING, IT WAS OBSERVED THAT WITH PLAY IN THE BLADE HEAD, THERE WAS BLACK LIQUID COMING OUT OF THE AIR OSCILLATOR DEVICE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694060 ↗
• MalfunctionFeb 28, 2022Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power; Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS STICKY, THE DEVICE MADE AN EXCESSIVE NOISE, AND THE SAW HEAD COULD NOT BE ROTATED OR LOCKED IN A NEW POSITION. IT WAS DETERMINED THAT THE DEVICE HAD A CORRODED BEARING, A WORN SEAL, AND COSMETIC DAMAGE ¿ WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK POSITIONING OF SAW HEAD, CHECK FOR STICKY TRIGGER AND CHECK FOR NOTICEABLE NOISE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620171 ↗
• MalfunctionFeb 22, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE HAD A STICKY TRIGGER AND WOULD NOT RUN DUE TO DEFECTIVE TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK FOR STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK WHILE IN USE WITH A COMPACT AIR DRIVE DEVICE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576138 ↗
• MalfunctionFeb 18, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE WAS LEAKING AIR, HAD LOW POWER, MADE UNEXPECTED NOISE, UNINTENDED ACTIVATION AND THE TRIGGER WAS STICKY. THE DEVICE ETCHING WAS ILLEGIBLE, THE COUPLING WAS WORN AND THE SAW HEAD COULD NOT BE ROTATED IN THE LOCKED / ROTATED IN THE NEW POSITION. THE DEVICE ALSO FAILED PRETESTS FOR AIR LEAK, THE STARTING BEHAVIOR, THE OSCILLATING FREQUENCY WITH FREQUENCY METER, NOTICEABLE NOISE, UNINTENDED MOTION, STICKY TRIGGER, SYMMETRY FROM SAW HEAD TO THE HANDPIECE HANDLE, POSITIONING OF SAW HEAD, MARKING & LABELING AND GENERAL CONDITION. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563355 ↗
• MalfunctionJan 24, 2022Unintended System Motion; Fail-Safe Problem; Failure to Auto Stop; Physical Resistance/Sticking; Complete Loss of Power; Unintended System Motion; Fail-Safe Problem; Failure to Auto Stop; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE WOULD RUN IN THE LOCKED POSITION, THE HOUSING WAS WORN, MOVING PARTS OF THE TRIGGER DID NOT MOVE SMOOTHLY, HAD COMPONENT DAMAGE, A STICKY TRIGGER, WOULD NOT RUN, UNINTENDED ACTIVATION/MOTION, AND WAS MAKING AN UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK TRIGGER LOCKING (SAFETY SYSTEM), CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, CHECK FOR UNINTENDED MOTION, CHECK FOR NOTICEABLE NOISE, AND CHECK OSCILLATING FREQUENCY. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333318 ↗
• MalfunctionJan 20, 2022Unintended System Motion; Complete Loss of Power; Unintended System Motion; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE HAD UNINTENDED ACTIVATION/MOTION, AND CORROSION/RUSTING/PITTING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR UNINTENDED MOTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310793 ↗
• MalfunctionJan 14, 2022Unintended System Motion; Complete Loss of Power; Unintended System Motion; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER OF THE AIR OSCILLATOR DEVICE WAS INSUFFICIENT/LOW, AND THE LABELING WAS ILLEGIBLE AND ETCHING. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD AN UNINTENDED ACTIVATION/MOTION, UNEXPECTED NOISE, COMPONENT DAMAGE, AN AIR LEAK, AND A COSMETIC DAMAGE. IT WAS DETERMINED THAT THE SAW HEAD COULD NOT BE ROTATED OR LOCKED IN A NEW POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK SYMMETRY FROM SAW HEAD TO THE HANDPIECE HANDLE, CHECK FOR UNINTENDED MOTION, CHECK FOR NOTICEABLE NOISE, CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER, CHECK THE STARTING BEHAVIOR AND CHECK FOR AIR LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261031 ↗
• MalfunctionJan 14, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS STICKY, AND THE LABELING WAS ILLEGIBLE AND ETCHING. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC AND COMPONENT DAMAGE, AND THE DEVICE WOULD NOT RUN DUE TO A DAMAGED MOTOR AND A DEFECTIVE TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK SAW BLADE QUICK COUPLING, CHECK TRIGGER LOCKING (SAFETY SYSTEM), CHECK FOR STICKY TRIGGER, CHECK FUNCTION OF DEVICE AND CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260504 ↗
• MalfunctionJan 14, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE HAD COMPONENT DAMAGE, A STICKY TRIGGER, THE MOTOR WAS DAMAGED ¿ WILL NOT RUN, WAS WORN, AND THE LOCKING MECHANISM WAS STIFF/STUCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OSCILLATION FREQUENCY, CHECK THE FUNCTION OF THE DEVICE, CHECK FOR STICKY TRIGGER, CHECK THE SAW BLADE QUICK COUPLING, AND GENERAL CONDITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260371 ↗
• MalfunctionJan 14, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE HAD COMPONENT DAMAGE, COULD NOT SECURE/LOCK THE CUTTER, MOVING PARTS OF THE TRIGGER DID NOT MOVE SMOOTHLY, AND A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK SAW BLADE QUICK COUPLING, AND CHECK FOR STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259757 ↗
• MalfunctionJan 14, 2022Unintended System Motion; Physical Resistance/Sticking; Complete Loss of Power; Unintended System Motion; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE HAD, A STICKY TRIGGER, WAS WORN, WOULD NOT RUN, COMPONENT DAMAGE, AND THE DEVICE WOULD RUN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK TRIGGER LOCKING (SAFETY SYSTEM), CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, AND CHECK OSCILLATION FREQUENCY. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259198 ↗
• MalfunctionJan 11, 2022Noise, Audible; Complete Loss of Power; Noise, Audible; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE WAS MAKING EXCESSIVE NOISE. IT WAS DETERMINED THAT THE DEVICE WAS WORN WITH COSMETIC DAMAGE, HAD COMPONENT DAMAGE TO THREAD SAW BLADE COUPLING, ILLEGIBLE ETCH, INSUFFICIENT/LOW POWER AND AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECKING SAW BLADE QUICK COUPLING, CHECKING FOR NOTICEABLE NOISE, CHECKING OSCILLATION FREQUENCY WITH FREQUENCY METER AND CHECKING FOR AIR LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226907 ↗
• MalfunctionDec 20, 2021Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE COULD NOT SECURE/LOCK THE CUTTER DEVICE, THE LOCKING MECHANISM WAS STUCK/STIFF, HAD A STICKY TRIGGER, WOULD NOT RUN ¿ TRIGGER DEFECTIVE, THE MOTOR WAS WORN, THE THREAD ON THE SAW BLADE COUPLING WAS DAMAGED, AND THE HOUSING WAS DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE SAW BLADE QUICK COUPLING, CHECK TRIGGER LOCKING (SAFETY SYSTEM), CHECK FOR STICKY TRIGGER, CHECK FUNCTION OF THE DEVICE, AND CHECK OSCILLATING FREQUENCY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046840 ↗
• MalfunctionNov 15, 2021Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED FROM THE (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AIR OSCILLATOR DEVICE STOPPED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810637 ↗
• MalfunctionNov 3, 2021Leak/Splash; Output below Specifications; Leak/Splash; Output below Specifications

  IT WAS REPORTED FROM (B)(6) THAT THE MOTOR OF THE AIR OSCILLATOR DEVICE (SAW AND PERFORATOR) DID NOT HAVE THE STRENGTH NECESSARY TO APPLY A LOT OF PRESSURE TO CUT THE BONE, AND THE DEVICE WAS THROWING LUBRICANT DUE TO THE PRESSURE APPLIED BY THE SPECIALIST. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 201. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746780 ↗
• MalfunctionOct 29, 2021Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS STICKY, AND THE DEVICE HAD A COSMETIC DAMAGE DUE TO A WORN HOUSING. IT WAS FURTHER OBSERVED THAT THE DEVICE WOULD NOT RUN, HAD A COMPONENT DAMAGE AND CORRODED BEARING. IT WAS OBSERVED THAT THE SEAL AND GEAR WERE WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER, CHECK FUNCTION OF DEVICE, CHECK FOR STICKY TRIGGER AND GENERAL CONDITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721322 ↗
• MalfunctionOct 11, 2021Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS STICKY, AND THE DEVICE HAD A COSMETIC DAMAGE DUE TO A WORN HOUSING. IT WAS FURTHER OBSERVED THAT THE DEVICE WOULD NOT RUN AND HAD A COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK TRIGGER LOCKING, CHECK FOR STICKY TRIGGER, CHECK FUNCTION OF DEVICE AND CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606798 ↗
• MalfunctionSep 15, 2021Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRIGGER OF THE SMALL BATTERY DRIVE DEVICE WAS STICKY, AND THE SAW HEAD COULD NOT BE ROTATED OR LOCKED IN THE NEW POSITION. IT WAS FURTHER OBSERVED THAT THE MOTOR WAS DAMAGED, AND THE DEVICE WOULD NOT RUN. IT WAS DETERMINED THAT THE LABELING WAS ILLEGIBLE AND ETCHING, THE HOUSING WAS WORN- COSMETIC DAMAGE, AND THE DEVICE HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK POSITIONING OF SAW HEAD, CHECK SYMMETRY FROM SAW HEAD TO THE HANDPIECE HANDLE, CHECK TRIGGER LOCKING, CHECK FUNCTION OF DEVICE AND CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474769 ↗
• MalfunctionAug 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED FROM (B)(6) THE TRIGGER OF THE AIR OSCILLATOR DEVICE WAS LOCKING. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282519 ↗
• MalfunctionAug 3, 2021Noise, Audible; Complete Loss of Power; Noise, Audible; Complete Loss of Power

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER OF THE AIR OSCILLATOR DEVICE WAS INSUFFICIENT/LOW. IT WAS FURTHER OBSERVED THAT THE SEAL WAS WORN, AND THE DEVICE HAD A COMPONENT DAMAGE, AN AIR LEAK, A WORN MOTOR AND MAD AN EXCESSIVE NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR AIR LEAK, CHECK OSCILLATING FREQUENCY WITH FREQUENCY METER, CHECK FOR NOTICEABLE NOISE AND CHECK POSITIONING OF SAW HEAD. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267281 ↗