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RUSCH IPN048387 (REF 004551004)Recalls & reported problems

Teleflex Incorporated · RUSCH GREENLITE SU MTL BLADE MAC 4 · Class 1

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14026737626088), received between Apr 20, 2021 and Apr 11, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break6
  • Fitting Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information2
  • Hypoxia1
  • Low Oxygen Saturation1
  • Obstruction/Occlusion1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 11, 2023Break; Break

    IT WAS REPORTED THAT "THE NURSE [REPORTED] THAT SHE HAD LITTLE VISIBILITY DURING INTUBATION AND THEN SHE REALIZED THAT THE LARYNGOSCOPE BLADE WAS BROKEN. THE FIBER OPTIC LIGHT IS SEPARATED FROM THE BLADE.". MULTIPLE ATTEMPTS WERE MADE TO INQUIRE WHETHER ANY PLASTIC PARTS ENTERED THE PATIENT AND IT THEY WERE REMOVED, THE CURRENT CONDITION OF THE PATIENT, IF THERE WAS ANY PATIENT HARM DURING OR AFTER THE PROCEDURE, IF ANY MEDICAL INTERVENTION WAS PERFORMED, AND HOW THE INCIDENT WAS RESOLVED. THE CUSTOMER DID NOT RETURN ANY OF OUR INQUIRIES. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Patient problems: Insufficient Information

    MAUDE report 16712945 ↗
  • MalfunctionFeb 11, 2022Break; Break

    IT WAS REPORTED THAT: "INCIDENT HAPPENED IN THE ANAESTHESIA DEPARTMENT. WHILE SNAPPING THE BLADE TO THE LARYNGOSCOPE HANDLE, THE PLASTIC PART BROKE INTO SEVERAL PIECES AT THE LEVEL OF THE CONNECTOR". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13514991 ↗
  • MalfunctionNov 12, 2021Break; Break

    COMPLAINT FROM MAUDE DATABASE: IT WAS REPORTED "THE LIGHT SOURCE FROM THE SINGLE USE GREEN RUSCHLITE METAL LARYNGOSCOPE BLADE FELL OFF THE BLADE WHEN ATTEMPTING TO USE ON A PATIENT. IT WAS ABLE TO BE RETRIEVED AND THERE WAS NO ADVERSE PATIENT OUTCOME". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12807299 ↗
  • MalfunctionSep 8, 2021Break; Break

    IT WAS REPORTED "THE ANAESTHETIST [REPORTED] THAT DURING TRACHEAL INTUBATION A PLASTIC PIECE OF THE DEVICE WAS SEEN INSIDE THE PATIENTS MOUTH. THERE WAS NO APPARENT INJURY CAUSED TO THE PATIENT. FURTHER INVESTIGATIONS CONDUCTED TO LOCATE THE PIECE. LUNGS AND OESOPHAGUS CHECKED AS WELL AS THE SURROUNDING AREA, IN CASE HAD COME OUT". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Obstruction/Occlusion

    MAUDE report 12440538 ↗
  • MalfunctionJun 23, 2021Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT: "THE BLADE DID NOT CONNECT PROPERLY ON THE HANDLE HEINE F22, SO THERE WAS NO LIGHT. CLINICAL CONSEQUENCES: DELAY IN THE TREATMENT INVOLVING A FEMALE PATIENT WHO WAS ALREADY IN HYPOXEMIA". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Hypoxia

    MAUDE report 12054128 ↗
  • MalfunctionJun 23, 2021Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT: "THE BLADE DID NOT CONNECT PROPERLY ON THE HANDLE HEINE F22, SO THERE WAS NO LIGHT". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: Low Oxygen Saturation

    MAUDE report 12054087 ↗
  • MalfunctionApr 26, 2021Break; Break

    IT WAS REPORTED ""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". NO PATIENT HARM OR INJURY REPORTED DURING PROCEDURE AND REPLACEMENT DEVICE WAS USED SUCCESSFULLY.

    Patient problems: Insufficient Information

    MAUDE report 11723301 ↗
  • MalfunctionApr 20, 2021Break; Break

    IT WAS REPORTED THAT "WHEN THE USER SNAPPED THE BLADE ON THE HANDLE THE CLEAR PLASTIC BROKE AND DISCONNECTED FROM THE HANDLE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11697262 ↗

Other LARYNGOSCOPE, RIGID devices

All LARYNGOSCOPE, RIGID devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.