XPS® 1897200Recalls & reported problems
Medtronic Xomed, Inc. · HANDPIECE 1897200 MAGNUM II EN ROHS · Class 2
All models of XPS (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic Xomed Magnum II surgical drill handpiece used in ENT procedures. The 45 reports mostly describe the handpiece heating up within a minute of use, plus some sticking, wobbling or vibrating burs, with no patient involvement noted. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00643169360846), received between Dec 2, 2016 and Aug 27, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (43 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device43
- Mechanical Jam6
- Noise, Audible2
- Vibration2
- Complete Loss of Power1
- Grounding Malfunction1
- Intermittent Loss of Power1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Patient Involvement8
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Overheating of Device
It was reported that pre-op, the M2 handpiece has heating issue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471566 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WOBBLES IN M2 HANDPIECE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319552 ↗MalfunctionDec 27, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRE-OP, THE M2 HANDPIECE HAD HEATING ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025276 ↗MalfunctionSep 9, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO PROCEDURE MAGNUM HANDPIECE HAD HEATING ISSUE. IT WAS FURTHER STATED OVERHEATING WAS NOTICED WITH IN A MINUTE OF USAGE. THE DEVICE WAS RUN ON OSCILLATE MODE AT 3000RPM. IRRIGATION WAS USED AT THE FLOW RATE OF 15CC/MIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167433 ↗MalfunctionJun 20, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE BLADE HAD VIBRATING ISSUE IN THE M2 HANDPIECE. THE HANDPIECE WAS CHECKED WITH ANOTHER BLADE AND THE PROBLEM WAS STILL THE SAME. BUT WHEN THE BLADE WAS CHECKED WITH ANOTHER HANDPIECE IT WAS WORKING FINE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19572907 ↗MalfunctionJun 11, 2024Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE HEATED UP WITHIN A MINUTE AT 3000 RPM SPEED IN OSCILLATION MODE, AND IRRIGATION WAS USED AT 15 CC/MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508154 ↗MalfunctionMar 26, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
IT WAS REPORTED THAT PRE-OPERATIVE, THE BLADES WERE NOT ROTATING IN THE HANDPIECE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, DURING TESTING IT TOOK LESS THAN A MINUTE TO OVERHEAT. THE DEVICE WAS RUNNING AT 3000RPM IN OSCILLATING MODE WITH NO IRRIGATION BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18976497 ↗MalfunctionMar 18, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING PRE-OP THAT THE DEVICE HAD HEATING ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920322 ↗MalfunctionOct 16, 2023Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS BEING RUN AT 6000 RPM IN OSCILLATION MODE. 35CC OF IRRIGATION WAS USED. THE PROCEDURE WAS COMPLETED USING STANDBY SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17938359 ↗MalfunctionSep 21, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING INTRA-OP, THE M2 HANDPIECE WAS NOT TURNING AND OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17787107 ↗MalfunctionSep 1, 2023Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
AS PER THE ADDITIONAL INFORMATION RECEIVED ABOUT THE PRE-REPAIR TEMPERATURES I.E., RECORDED TEMPERATURES WERE LESS THAN 118.4 °F WHEN TESTED FOR ONE MINUTE HENCE DOES NOT MEET REPORTING CRITERIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667666 ↗MalfunctionAug 14, 2023Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED THAT THE HANDPIECE WAS BEING USED MORE THAN ONE MINUTE WHEN OVERHEATING WAS NOTICED. THE DEVICE RAN AT A SPEED OF 2000-3000 RPM IN OSCILLATION MODE. THE IRRIGATION FLOW RATE WAS 30CC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17538456 ↗MalfunctionJan 11, 2023Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED THAT HANDPIECE WAS OVER HEATING IN ONE MINUTE. SURGERY HAS BEEN COMPLETED WITH ANOTHER MICRODEBRIDER WITH 3500 RPM SPEED, AND IT WAS USED IN OSCILLATION MODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16138589 ↗MalfunctionDec 19, 2022Grounding Malfunction; Overheating of Device; Grounding Malfunction; Overheating of Device
IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT INTRA OP FOR M2 HANDPIECE OVERCURRENT ERROR APPEARS AT IPC WITH INTERMITTENT AND RUNNING WITH HEAT AT MOTOR PART. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16004573 ↗MalfunctionSep 29, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INTRA-OP, THE DEVICE OVERHEATED. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP THE HEATING ISSUE OCCURRED LESS THAN ONE MINUTE, PROCEDURE COMPLETED USING BACK UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505476 ↗MalfunctionSep 15, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS NOT WORKING AND HEATING ISSUE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15424883 ↗MalfunctionSep 13, 2022Overheating of Device; Overheating of Device
HEALTHCARE PROFESSIONAL REPORTED THAT PRE-OP, THE DEVICE WAS OVERHEATING. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15414490 ↗MalfunctionAug 10, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING PRE-OP HANDPIECE WAS HEATING AND BLADE NOT ROTATING. NO PATIENT INVOLVED IN EVENT. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15203911 ↗MalfunctionJul 4, 2022Overheating of Device; Overheating of Device
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING PRE-OP HANDPIECE HAD HEATING PROBLEM. NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14907373 ↗MalfunctionJun 9, 2022Overheating of Device; Overheating of Device
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING PRE-OP HANDPIECE MOTOR GETTING HEAT AND STRUCK. THERE WAS NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14641846 ↗MalfunctionMar 23, 2022Overheating of Device; Overheating of Device
A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA DISTRIBUTOR THAT THE HANDPIECE OVERHEATED DURING OPERATION. THERE IS NO PATIENT IMPACT. UPON FOLLOW UP, IT WAS REPORTED THAT THE DEVICE OVERHEATED IN LESS THAN A MINUTE. THEY TURNED ON THE POWER, CONNECTED THE HANDPIECE TO THE CONSOLE, STEPPED ON THE PEDAL, AND IT GOT HOT DURING USE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE BUT A BACK UP DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13866962 ↗MalfunctionMar 10, 2022Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE WAS HEATING UP AND THE BLADE WAS NOT ROTATING. EVENT FOUND PRE-OP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721130 ↗MalfunctionFeb 3, 2022Overheating of Device; Overheating of Device
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THE DEVICE WAS HEATING UP AND NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13439711 ↗MalfunctionDec 9, 2021Overheating of Device; Overheating of Device
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE GOT HEATED DURING PRE-OP. THERE IS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12967943 ↗MalfunctionDec 7, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE HANDPIECE MOTOR WAS NOT WORKING AND HEATING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954197 ↗
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page