RUSCH IPN048386 (REF 004551003)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 14026734626074), received between Jul 8, 2019 and Apr 29, 2022 — classified as 1 death, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED "PRIOR TO INTUBATION THE HINGE AND LIGHT PIPE WERE DISLODGED FROM THE BLADE". ADDITIONAL INFORMATION STATES "PER THE ANESTHESIA PROVIDER THE BLADE SPLIT IN HALF AND THE TOP PART AND LIGHT PART FELL OFF AS WELL". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255317 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT "DURING INTUBATION A SMALL PART OF THE FIBER OPTIC FALLS DOWN INTO THE ESOPHAGUS". ADDITIONAL INFORMATION RECEIVED STATED THAT "IT HAS BEEN REMOVED AFTER THE GASTROSCOPE PROCEDURE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667367 ↗
• MalfunctionFeb 7, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT "THE HOSPITAL FACED TWO INCIDENTS DURING A SITUATION OF EMERGENCY INTUBATION PROCEDURE. THE BLADE DID NOT SNAP PROPERLY ON THE HANDLE. THE CONSEQUENCE WAS A LIGHTING FAULT AND A DAMAGE OF THE HANDLE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13476314 ↗
• MalfunctionFeb 7, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT "THE HOSPITAL FACED TWO INCIDENTS DURING A SITUATION OF EMERGENCY INTUBATION PROCEDURE. THE BLADE DID NOT SNAP PROPERLY ON THE HANDLE. THE CONSEQUENCE WAS A LIGHTING FAULT AND A DAMAGE OF THE HANDLE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13476305 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT: "DURING A LARYNGOSCOPY INTO THE PATIENT, A SLIGHT UNUSUAL NOISE WAS HEARD FROM THE BLADE. THE LIGHT FROM THE BLADE WAS LESS BRIGHT SO IT MADE THE INTUBATION MORE DIFFICULT TO PERFORM. NEVERTHELESS THERE WAS NO CONSEQUENCE FOR THE PATIENT. WHEN CHECKING AFTER THE LARYNGOSCOPY PROCEDURE (OUTSIDE THE PATIENT), ONE PART OF THE BLADE WAS CRACKED AND THEN BROKE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446716 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT: "A PIECE OF THE CLEAR PLASTIC PART BROKE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205088 ↗
• MalfunctionOct 5, 2021Break; Break

  CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579852 ↗
• MalfunctionOct 5, 2021Break; Break

  CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579822 ↗
• MalfunctionOct 5, 2021Break; Break

  CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579804 ↗
• MalfunctionOct 5, 2021Break; Break

  CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579792 ↗
• DeathMar 16, 2021Break; Break

  IT WAS REPORTED THAT "THE ANAESTHETIST TRIED TO CONNECT THE BLADE TO THE HANDLE, BUT HE FACED DIFFICULTY AND THE PLASTIC PART OF THE BLADE BROKE AT THE CONNECTION LEVEL. THERE WAS A DELAY IN THE PROCESS OF THE INTUBATION BECAUSE THE STAFF NEEDED GET A SPARE DEVICE. THE STAFF GRABBED AND USED ANOTHER DEVICE WORKING PROPERLY. THE PATIENT DECEASED BUT THERE IS NO LINK WITH THE INCIDENT. HE DIED FROM A NATURAL CAUSE."

  Patient problems: Insufficient Information

  MAUDE report 11493803 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT "IN A LIFE-THREATENING EMERGENCY SITUATION, IN ORDER TO PERFORM AN INTUBATION, THE ANAESTHETIST FACED AN ISSUE USING THE LARYNGOSCOPE AND ITS BLADE. THE ANAESTHETIST TRIED TO CONNECT THE BLADE TO THE HANDLE BUT, HE FACED DIFFICULTY AND FOUND IT IMPOSSIBLE TO CONNECT, HE FORCED TO MAKE THE CONNECTION AND THE PLASTIC PART OF THE BLADE BROKE AT THE CONNECTION LEVEL. THE BLADE AND THE HANDLE (TELEFLEX DEVICE CAT# 4411100) USED WERE BOTH IN THE EMERGENCY CART. CLINICAL CONSEQUENCE: THERE WAS A DELAY IN THE PROCESS OF THE INTUBATION BECAUSE THE STAFF NEEDED GET A SPARE DEVICE".

  Patient problems: Insufficient Information

  MAUDE report 11493731 ↗
• MalfunctionJul 8, 2019Break; Crack; Material Separation

  DURING ROUTINE LARYNGOSCOPY, THE BLADE SEPARATES FROM THE WEDGE, CRACKING THE FIBEROPTIC LIGHT CHANNEL RENDERING THE DEVICE NONFUNCTIONAL. AN ADD'L BLADE WAS OPENED AND USED SUCCESSFULLY. NO DAMAGE WAS DONE TO THE PT, BUT THE TEETH COULD EASILY HAVE BEEN DAMAGED BY THE BREAKAGE. INTUBATION WAS DELAYED. WE HAVE ALSO EXPERIENCED MULTIPLE BREAKAGE EVENTS IN THE PAST SEVERAL WEEKS OF A SIMILAR NATURE WITH VARIOUS OTHER LOTS OF THIS BLADE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8772775 ↗