N/A 1884068HS (UDI 20681490692919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20681490692919), received between Jan 18, 2017 and Sep 8, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  It was reported that, the cutters of the M5 engine broke in half after about ten minutes of use. There were no patient symptoms/injuries related to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50662372 ↗
• MalfunctionSep 8, 2026Break

  It was reported that, the cutters of the M5 engine broke in half after about ten minutes of use. There were no patient symptoms/injuries related to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50662306 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, INTRA-OPERATIVELY DURING ENDOSCOPIC SINUS SURGERY, THE METAL PART OF THE OUTER TUBE OF THE RELEVANT BUR WAS DEFORMED AND DAMAGED, SO ITS USE WAS DISCONTINUED. A FRAGMENT BECAME DISLODGED. THE METAL PART OF THE OUTER TUBE NEAR THE TIP WAS DAMAGED AND BROKE OFF. THE PROCEDURE WAS COMPLETED WITH BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695115 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIRST DIAMOND DRILL BIT FOR THE DACRIO BROKE. WHEN IT WAS REPLACED WITH ANOTHER, SHARP ONE, THE SAME THING HAPPENED, ALSO WITH THE SAME HANDPIECE AND THE SAME IRRIGATION SYSTEM. NO FRAGMENTS OR PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE MICRODEBRIDER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801507 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT ENDOSCOPIC DCR PROCEDURE, THE DCR BUR WAS PLACED IN AN M5 HANDPIECE. THE BUR DID NOT INITIALLY SPIN. THE BUR WAS ADJUSTED AND RESET IN THE M5. THE BUR THEN WORKED HOWEVER AT THE END OF THE CASE, THE BUR WAS BROKEN AND STUCK IN THE M5 AND CANNOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520052 ↗
• MalfunctionNov 17, 2023Break; Break

  IT WAS REPORTED THAT THE BUR COULD NOT BE REMOVED AFTER THE USE, AND THE BUR WAS DAMAGED. THERE WERE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159059 ↗
• MalfunctionJun 29, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING DCR PROCEDURE, WHEN THE DOCTOR USED THE BUR FOR ABOUT 3 MINUTES, IT WAS FOUND THE BUR COULDN'T TURN. THE BUR WAS THEN REMOVED AND FOUND THAT THE BUR WAS BROKE AT THE PROXIMAL END. THE INNER SHAFT END THAT CONNECTS TO THE HUB WAS FOUND BROKEN. FINALLY, THE DOCTOR CHANGED A BUR TO COMPLETE THE SURGERY.  THERE WERE NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN DEVICE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234845 ↗
• MalfunctionApr 25, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE HAD BROKEN DURING THE PROCEDURE AND IT WAS COMPLETED USING BACK UP DEVICE. NO PATIENT IMPACT. THERE IS NO PHYSICIAN (DOCTOR) OR OTHER HEALTHCARE PROFESSIONAL ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14195637 ↗
• MalfunctionJun 18, 2021Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING AN ENDOSCOPIC DACRYOCYSTORHINOSTOMY, THE BUR BROKE AFTER ONE MINUTE, PREVENTING THE BUR TO ROTATE. THERE WERE NO BROKEN PIECES REMAIN INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT AND INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024848 ↗
• MalfunctionNov 9, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT THE TWO BLADES GOT BROKEN IMMEDIATELY AFTER INTO USE DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE TWO BLADES WERE USED IN ONE OPERATION AND IT WAS THE INITIAL USE FOR BOTH BLADES. THE BLADE WAS USED TO DRILL THE BONE. THE BLADE WAS BROKEN BUT NOT DETACHED. THERE WAS NO ERROR CODE SHOWN ON THE POWER CONSOLE. THERE WAS NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE CASE WAS COMPLETED USING THE THIRD NEW BLADE. THERE WAS A LESS THAN 5 MINUTES DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO ADVERSE EFFECT OR PATIENT IMPACT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054755 ↗
• MalfunctionNov 9, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT THE TWO BLADES GOT BROKEN IMMEDIATELY AFTER INTO USE DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE TWO BLADES WERE USED IN ONE OPERATION AND IT WAS THE INITIAL USE FOR BOTH BLADES.THE BLADE WAS USED TO DRILL THE BONE. THE BLADE WAS BROKEN BUT NOT DETACHED. THERE WAS NO ERROR CODE SHOWN ON THE POWER CONSOLE. THERE WAS NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE CASE WAS COMPLETED USING THE THIRD NEW BLADE. THERE WAS A LESS THAN 5 MINUTES DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO ADVERSE EFFECT OR PATIENT IMPACT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054752 ↗
• MalfunctionOct 29, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT WHEN THE SURGEON STARTED THE SHAVER PRIOR TO THE PROCEDURE, THE BUR WAS BROKEN. A DIFFERENT BUR WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8013932 ↗
• MalfunctionSep 5, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A BUR BROKE INTRA-OPERATIVELY. BUR WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS CONFIRMED THROUGH A POST-OPERATIVE CT THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT¿S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7849290 ↗
• MalfunctionMar 9, 2018Break; Break

  THE CUSTOMER REPORTED THAT TWO HIGH SPEED BURS BROKE DURING USE. THERE WAS NO PATIENT INJURY. FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE BREAK OCCURRED APPROXIMATELY 1.5CM DISTAL FROM THE BASE OF THE BUR WITHIN THE OUTER TUBE. NO FRAGMENTS WERE PRODUCED AS A RESULT OF THE DAMAGE. INCIDENT 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327903 ↗
• MalfunctionMar 9, 2018Break; Break

  THE CUSTOMER REPORTED THAT TWO HIGH SPEED BURS BROKE DURING USE. THERE WAS NO PATIENT INJURY. FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE BREAK OCCURRED APPROXIMATELY 1.5CM DISTAL FROM THE BASE OF THE BUR WITHIN THE OUTER TUBE. NO FRAGMENTS WERE PRODUCED AS A RESULT OF THE DAMAGE. INCIDENT 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7327876 ↗
• MalfunctionJan 19, 2018Break; Break

  THE CUSTOMER REPORTED THAT APPROXIMATELY 10 MINUTES INTO A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY), THE BLADE BROKE. THE DOCTOR USED A REPLACEMENT BLADE TO COMPLETE THE SURGERY. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT. IT WAS THE INITIAL USE OF THE BLADE. THERE WAS NO FRAGMENT LEFT IN THE SURGICAL FIELD. THE SURGERY WAS DELAYED FOR APPROXIMATELY THREE MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207771 ↗
• MalfunctionJan 3, 2018Overheating of Device; Overheating of Device

  THE SURGEON REPORTED THAT DURING A PROCEDURE, THE BUR OVERHEATED, BURNED THE PATIENT, RESULTING IN AN ABRASION TO THE SKIN. THERE WAS NO SERIOUS INJURY REPORTED.

  Patient problems: Abrasion

  MAUDE report 7161576 ↗
• MalfunctionMay 1, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HIGH SPEED BUR BROKE AT THE BASE (BLUE HUB). THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6534802 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT SIX HIGH-SPEED BURS BROKE AT THE BASE OF EACH BUR DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372159 ↗
• MalfunctionJan 18, 2017Break; Break

  ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT AFTER THE BEGINNING OF USE, THE DEVICES BROKE IN TWO AND FELL ONTO THE PATIENT. THEY WERE SUCCESSFULLY REMOVED; THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260495 ↗