n.a. 11301BN1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551226698), received between Nov 8, 2021 and Nov 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2021Microbial Contamination of Device; Microbial Contamination of Device

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE AFFECTED FIBERSCOPE WAS USED FOR THE TREATMENT OF 2 PATIENTS. BOTH PATIENTS WERE INFECTED WITH A BACTERIUM CALLED PSEUDOMONAS AERUGINOSA, BUT NO SERIOUS DETERIORATION IN STATE OF HEALTH WAS REPORTED. THIS REPORT REPRESENTS THE EVENT FOR PATIENT 2 OF 2. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Respiratory Tract Infection

  MAUDE report 12770871 ↗
• InjuryNov 8, 2021Microbial Contamination of Device; Microbial Contamination of Device

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE AFFECTED FIBERSCOPE WAS USED FOR THE TREATMENT OF 2 PATIENTS. BOTH PATIENTS WERE INFECTED WITH A BACTERIUM CALLED PSEUDOMONAS AERUGINOSA, BUT NO SERIOUS DETERIORATION IN STATE OF HEALTH WAS REPORTED. THIS REPORT REPRESENTS THE EVENT FOR PATIENT 1 OF 2. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Respiratory Tract Infection

  MAUDE report 12770869 ↗