Polaris 100/200 G16980Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048675268109), received between Sep 15, 2022 and Feb 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.

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.

• MalfunctionFeb 26, 2024Loose or Intermittent Connection; Detachment of Device or Device Component; Device Fell; Loose or Intermittent Connection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE USER FOUND A GAP BETWEEN THE JOINT DURING THE SURGICAL CHANGE PERIOD AND INDICATED THAT IT MAY FALL OFF. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775607 ↗
• MalfunctionNov 23, 2023Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE LIGHT HEAD OF A POLARIS 100/200 FELL DURING A PROCEDURE WITH A PATIENT. IN THE COURSE OF THE INVESTIGATION, HOWEVER, IT WAS CONFIRMED BY THE COMPLAINANT THAT THE LIGHT HEAD BECAME LOOSE AND HAD LOWERED BUT ¿ OTHER THAN INITIALLY REPORTED - DID NOT FALL. THERE WAS NO INJURY REPORTED NEITHER IN TERMS OF THE PATIENT NOR ANY OTHER PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197905 ↗
• MalfunctionOct 25, 2023Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING THE INSTALLATION OF THE DEVICE, IT WAS FOUND THAT THE JOINT OF THE LIGHT HEAD WAS DETACHED. NEITHER PATIENT NOR USER HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18002391 ↗
• MalfunctionOct 25, 2023Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING USE OF THE DEVICE, IT WAS FOUND THAT THE JOINT OF THE LIGHT HEAD WAS DETACHED. NEITHER PATIENT NOR USER HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002156 ↗
• MalfunctionOct 17, 2022Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE LAMP CANOPY OF THE POLARIS 100/200 HAD SEPARATED FROM THE ARM. IT HAPPENED DURING THE OPERATION, WHEN THE PATIENT WAS ALREADY ANESTHETIZED AND THE OPERATION WAS STARTED USING A SURGICAL ROBOT. HOWEVER, THE LAMP CANOPY WAS CAUGHT AND THEN PROVISIONALLY SECURED, THE TREATMENT WAS COMPLETED. NEITHER PATIENT NOR USER INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614437 ↗
• MalfunctionSep 15, 2022Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING A SURGICAL PROCESS THE LIGHT SYSTEM BECAME DETACHED. AS REPORTED THE LIGHT SYSTEM DID NOT FALL COMPLETLY BUT REMAIND HANGING ON ITS WIRING ONLY. NO PATIENT OR USER WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428473 ↗