XPS® Straightshot® 1898200T (UDI 00643169350687)Recalls & reported problems
Medtronic Xomed, Inc. · MICRODEBRIDER 1898200T IGS M4 ROHS · Class 2
All models of XPS Straightshot (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic XPS Straightshot microdebrider is a powered surgical handpiece used in ear, nose and throat surgery. All 128 reports are malfunctions, with no injuries or deaths; most describe the handpiece overheating, and others describe blockages, vibration or noise. 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
- 129
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00643169350687), received between Dec 9, 2016 and Sep 28, 2026 — classified as 129 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (118 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device118
- Mechanical Jam9
- Use of Device Problem8
- Vibration8
- Noise, Audible6
- Display or Visual Feedback Problem4
- Intermittent Energy Output2
- Intermittent Loss of Power2
Patient problems
- No Clinical Signs, Symptoms or Conditions83
- No Consequences Or Impact To Patient23
- No Patient Involvement14
- No Known Impact Or Consequence To Patient11
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
It was reported that, the M4 was not working. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911500 ↗MalfunctionSep 24, 2026Overheating of Device
It was reported that intra operatively, after the 0-degree blade was opened, the procedure could not be completed because the handpiece malfunctioned, overheated, and stopped working. The overheating was noticed when used for less than one minute. The handpiece was run at 5000 rpm speed with reciprocating rotation mode and irrigation was being used. As a result, the surgery was not finished. The hospital then used another brand of powered system with a new blade head to restart the procedure and complete the surgery. There is suspicion of connection issue with the blade. There was delay of surgery for few minutes. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879928 ↗MalfunctionAug 5, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137304 ↗MalfunctionJul 14, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25810841 ↗MalfunctionJul 5, 2026Overheating of Device
IT WAS REPORTED THAT PRE-OPERATION, THE M4 HANDPIECE WAS HEATING UP IN LESS THAN ONE MINUTE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712530 ↗MalfunctionDec 26, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894627 ↗MalfunctionJun 18, 2025Overheating of Device; Incorrect, Inadequate or Imprecise Result or Readings; Overheating of Device; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, THE HANDPIECE IS NOT FUNCTIONING DUE TO A BLOCKAGE INSIDE, OVERHEATING AFTER PRESSING THE FOOT SWITCH AND BLADE NOT ROTATING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22266029 ↗MalfunctionMay 26, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083216 ↗MalfunctionApr 28, 2025Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking
IT WAS REPORTED THAT THE ROD GOT STUCK IN THE M4 MOTOR AND COULD NOT BE REMOVED. IN ADDITION, THE MOTOR GOT OVERHEATED AND THE FIRST DRILL BIT GOT MELTED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21916542 ↗MalfunctionApr 22, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
AS PER THE PRODUCT ANALYSIS, THE DEVICE PRE-REPAIR TEMPERATURE TEST RESULTS ARE GEAR: 84F, MOTOR: 86F, BEARING: 87F FOR ONE MINUTE. ALL TEMPERATURES ARE WITHIN SPECIFICATION I.E. LESS THAN 118F.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881333 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USE, THE M4 HANDPIECE HAD BUR WOBBLING. THERE WAS NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341969 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21320031 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT THE BEFORE OPERATION, THE BUR WOBBLES IN M4 HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319478 ↗MalfunctionFeb 4, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE BUR WAS WOBBLING. THERE WAS NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303213 ↗MalfunctionNov 13, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING PROCEDURE M4 HANDPIECE HAD EXCESSIVE HEAT. IT WAS FURTHER STATED OVERHEATING WAS NOTICED IN LESS THAN A MINUTE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20671142 ↗MalfunctionOct 28, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT M4 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541848 ↗MalfunctionOct 21, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE OP, ABOVE 3000 RPM , IN OSCILLATION MODE DEVICE NOT SMOOTHLY WORKING WITH NEXUS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490629 ↗MalfunctionSep 18, 2024Overheating of Device; Mechanical Jam; Intermittent Loss of Power; Overheating of Device; Mechanical Jam; Intermittent Loss of Power
ADDITIONAL INFORMATION RECEIVED STATING DEVICE WAS OVERHEATED WHEN USED MORE THAN A MINUTE WHEN RUNNING AT 5000RPM IN OSCILLATION MODE. DEVICE DID NOT AUTOMATICALLY ACTIVATED. HANDPIECE RUN WHEN THE FOOT SWITCH PRESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20244658 ↗MalfunctionAug 22, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DEVICE DOES NOT TURN ANYMORE AND THE MOTOR GETS HOT. THERE IS NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024340 ↗MalfunctionJul 23, 2024Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED STATED THAT THE HEATING WAS OBSERVED AFTER 2 MINUTES OF USE. THE HANDPIECE WAS BEING RUN A 3000 RPM IN OSCILLATE MODE WITH NO IRRIGATION BEING USED. THE PROCEDURE WAS COMPLETED MANUALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19803962 ↗MalfunctionJun 24, 2024Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output
ADDITIONAL INFORMATION RECEIVED STATED THAT ANOTHER UNIT WAS SET UP TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19594855 ↗MalfunctionJun 3, 2024Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED THAT THE OVERHEATING WAS NOTICED IN LESS THAN ONE MINUTE. THE DEVICE BEING RUN AT 5000RPM AND RUN AT OSCILLATE MODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19445027 ↗MalfunctionMar 22, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INTRA OP DEVICE WAS OVERHEATING. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961819 ↗MalfunctionMar 20, 2024Overheating of Device; Overheating of Device
HANDPIECE WAS GETTING HOT WHEN IN USE IN 1-2 MINUTES. IT WAS RUNNING AT 5000RPM, OSCILLATION MODE, 25CC FLOWRATE. BACKUP DEVICE WAS USED FOR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18938612 ↗MalfunctionFeb 12, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED, THAT DURING PRE OP. THE M4 HANDPIECE IS GETTING OVERHEAT, DURING USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18692458 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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