XPS® 1898200TRF (UDI 00613994598301)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00613994598301), received between Dec 22, 2016 and Feb 2, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (23 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE M4 HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231405 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, BLADE WAS WOBBLING WHEN USED WITH M4 HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341663 ↗
• MalfunctionSep 2, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT M4 HANDPIECE WAS GETTING HOT. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117121 ↗
• MalfunctionSep 2, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE HANDPIECE RUNS CONTINUALLY ON ITS OWN AND WAS NOT SPINNING CORRECTLY. THERE WAS NO PATIENT IMPACT. FOLLOWED UP INFORMATION INDICATE THAT THE CASE WAS COMPLETED WITH THE BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15344410 ↗
• MalfunctionJun 19, 2022Overheating of Device; Overheating of Device

  HCP REPORTED THAT INTRA-OP, THE DEVICE OVERHEATED. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741262 ↗
• MalfunctionMar 31, 2022Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEATED. THERE IS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT ISSUE WAS NOTED DURING A PROCEDURE. THE HAND PIECE WAS NOTED TO BE OVER HEATING DURING USE THAT THE SURGEON AND NOTED IT WAS VERY HOT TO THE TOUCH IN HIS HAND. IT WAS BEING USED DURING A SINUS/NOSE PROCEDURE AND WAS USING IT FOR POLYPS AND SUBMUCOSAL RESECTION, IT WAS THE PROCEDURE. USER DID END UP USING ANOTHER XOMED SHAVER FOR THE CASE BECAUSE THE SURGEON DIDN T WANT TO CONTINUE TO USE THE HAND PIECE THAT WAS OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969553 ↗
• MalfunctionNov 4, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE IS NOT ROTATING AND HEATING UP DURING INTRA-OP. THERE IS NO PATIENT IMPACT REPORTED. UPON FOLLOW UP, IT WAS REPORTED THAT STAFF DIDN'T RECALL HOW FAST THE HANDPIECE WAS HEATING UP, HOWEVER THERE IS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750852 ↗
• MalfunctionAug 25, 2021Overheating of Device; Failure to Disconnect; Activation Problem; Overheating of Device; Failure to Disconnect; Activation Problem

  IT WAS REPORTED THAT THE HANDPIECE OVERHEATS AND STOPPED WORKING. THEY ARE ALSO UNABLE TO REMOVE THE DRILL BIT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367474 ↗
• MalfunctionAug 24, 2021Overheating of Device; Overheating of Device

  ON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE BEGAN TO OVERHEAT AFTER MORE THAN A MINUTE PRIOR TO AN ENDOSCOPIC SINUS PROCEDURE. VERY MINIMAL DELAY OCCURRED. A BACK-UP DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362502 ↗
• MalfunctionJun 16, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER REPORTED THAT THE HANDPIECE HAD AN EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007583 ↗
• MalfunctionApr 29, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743898 ↗
• MalfunctionMar 29, 2021Overheating of Device; Power Problem; Noise, Audible; Overheating of Device; Power Problem; Noise, Audible

  A HEALTH CARE PROVIDER REPORTED THAT THE HANDPIECE WAS MAKING A STRANGE SOUND, TURNING SLOW AND GETTING WARM DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, IT WAS STATED THAT THE EVENT OCCURRED DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY AND IT WAS UNSURE HOW LONG IT TOOK THE HANDPIECE TO OVERHEAT. A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581070 ↗
• MalfunctionDec 29, 2020Unintended System Motion; Overheating of Device; Unintended System Motion; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A HANDPIECE DID NOT STOP SPINNING, SMELL/FELT HOT POST-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088738 ↗
• MalfunctionJul 7, 2020Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER REPORTED THAT THE HANDPIECE WAS OVERHEATING DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238896 ↗
• MalfunctionOct 25, 2019Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE WAS GETTING WARM AND THE MOTOR WAS MAKING A FUNNY NOISE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9239011 ↗
• MalfunctionJun 27, 2019Display or Visual Feedback Problem; Overheating of Device; Display or Visual Feedback Problem; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS HEATING UP PRIOR TO THE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

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

  MAUDE report 8739570 ↗
• MalfunctionNov 21, 2018Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED SUDDENLY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH NASAL POLYPECTOMY PROCEDURE. WITHIN MINUTES, THE DEVICE WAS HOT TO TOUCH, THEN THE HANDPIECE STOPPED WORKING. THE CASE WAS COMPLETED BUT THERE WAS AN HOUR DELAY AS THEY HAD TO GET THE OTHER DEVICE FROM ANOTHER HOSPITAL BY CAB. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8094551 ↗
• MalfunctionOct 23, 2018Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS MAKING A HUMMING NOISE AND WAS RUNNING HOT DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7995479 ↗
• MalfunctionJun 28, 2018Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE DEVICE MOTOR IS GETTING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648227 ↗
• MalfunctionDec 22, 2017Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE HANDPIECE HEATED UP DURING THE CASE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7143643 ↗
• MalfunctionNov 2, 2017Overheating of Device; Overheating of Device

  THE CUSTOMER INDICATED THE HAND-PIECE WAS OVERHEATING DURING USE. NO PATIENT IMPACT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6998441 ↗
• MalfunctionFeb 14, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OPERATIVE THE DEVICE WAS RUNNING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6329977 ↗
• MalfunctionFeb 3, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OPERATIVE THE DEVICE GOT HOT AND WOULD NOT SPIN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301600 ↗
• MalfunctionJan 13, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TESTING THE DEVICE WAS NOISY AND RUNNING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6250559 ↗
• InjuryDec 22, 2016Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ¿PATIENT WAS SET FOR SURGERY TO REMOVE LARGE SINUS POLYP. ENT SURGEON BEGAN TO USE MICRODEBRIDER SHAVER HANDPIECE AND THERE WAS NO INDICATION THE HANDPIECE WAS WORKING (NO SOUND). REGISTER NURSE TURNED ON/OFF THE INTEGRATED POWER CONTROL PANEL (IPC) AND UNPLUGGED/PLUGGED IN THE HANDPIECE WITHOUT SUCCESS. A SECOND HANDPIECE WAS RETRIEVED AND THE IPC WAS RESTARTED, STILL WITHOUT SUCCESS (NO SOUND). A THIRD HANDPIECE WAS RETRIEVED. THERE WAS MINIMUM SOUND FROM THE DEVICE, BUT NO MOVEMENT. THIRD HANDPIECE DID WARM TO TOUCH. ENT SURGEON OPTED TO ABORT AND RESCHEDULE PROCEDURE DUE TO DELAY AND LENGTH OF TIME PATIENT WAS UNDER ANESTHESIA.¿ THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6199833 ↗