RUSCH IPN055757Recalls & reported problems
Teleflex Incorporated · RUSCH POLARIS FO BLADE MILLER 000 · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704734358), received between Nov 21, 2022 and Nov 21, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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
Device problems
- Material Protrusion/Extrusion2
Patient problems
- Insufficient Information2
- Abrasion1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED "REPORT OF INJURY TO BACK OF THROAT OF PATIENT". ADDITIONAL INFORMATION RECEIVED STATED THAT "CLINICIAN FELT BLADE SCRAPE BACK OF THROAT CAUSING VISIBLE INJURY WHEN INTUBATING PATIENT DURING TRANSPORT". ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE COMPLAINANT, NO INFORMATION RECEIVED AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT THE PATIENT CONDITION IS "FINE".
Patient problems: Abrasion; Insufficient Information
MAUDE report 15833565 ↗MalfunctionNov 21, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED "A REPORT OF LIP INJURY TO ONE BABY W/ USE OF OUR BLADE BY PROVIDER". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE [PHYSICIAN] INTUBATED THE PATIENT AND NOTICED THE LARYNGOSCOPE BLADE CUT THE BABY'S GUM, NO MEDICAL INTERVENTION PERFORMED". ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE COMPLAINANT, NO INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Laceration(s)
MAUDE report 15833521 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.