XPS® 1898200TRF (UDI 00643169882799)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169882799), received between Aug 16, 2019 and Dec 13, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAD RUNNING HOT WHEN IN USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316218 ↗
• MalfunctionMay 7, 2022Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14331354 ↗
• MalfunctionSep 14, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THERE WAS EXCESSIVE HEAT IN HANDPIECE DURING PRE-OP. THERE WAS NO PATIENT OR STAFF IMPACT. ON FOLLOW-UP IT WAS REPORTED THAT THE TYPE OF PROCEDURE PERFORMED WAS ENDOSCOPIC SINUS SURGERY. THERE WAS NO DELAY IN PROCEDURE AND BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467249 ↗
• MalfunctionMar 28, 2020Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE HANDPIECE WAS RUNNING HOT DURING SET-UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9893137 ↗
• MalfunctionMar 4, 2020Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A HANDPIECE WAS MAKING A HIGH PITCHED SOUND AND WAS HEATING UP DURING INSPECTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9784791 ↗
• MalfunctionAug 16, 2019Vibration; Vibration

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901340 ↗