RUSCH IPN041700Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704344229), received between Oct 4, 2022 and Jul 14, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE IN THE CLINICAL SETTING THE "BRONCHOSCOPE DOES NOT GO THROUGH THE ENDOBRONCHIAL TUBE WHILE INSERTE D." THE CLINICIANS USED ANOTHER DEVICE INSTEAD FROM A DIFFERENT MANUFACTURER TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326618 ↗
• InjuryApr 27, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE PEDIATRIC BRONCHOSCOPE DOESN'T GO WELL INSIDE THE ETT". AS A RESULT, THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH ANOTHER ETT. ADDITIONAL INFORMATION RECEIVED ON 5 MAY 2023 STATES THAT "THE PATIENT DID NOT DESATURATE. THERE WAS NO HARM TO THE THROAT NOR THE SUPERIOR AIRWAY. THE PROBLEM WAS THE IMPOSSIBILITY TO CONFIRM PROPER POSITIONING BECAUSE THE BRONCHOSCOPE COULD NOT ENTER THE TUBE. THE PROBLEM DID NOT OCCUR DURING THE INTUBATION, BUT WHILE VERIFYING PROPER POSITIONING IN THE BRONCHUS FOR SURGERY. THEY HAD TO EXTUBATE THE PATIENTS TO CHANGE THE DBL TUBE TO BE ABLE TO ENTER THE BRONCHOSCOPE IN THE TUBE. THEREFORE, AN EXTUBATING PROCESS WAS NEEDED AND THEN REINTUBATION (UNNECESSARY IF THE PROBLEM DID NOT OCCURRED WITH THE LEFT 35 DBL TUBE".

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

  MAUDE report 16824267 ↗
• InjuryApr 27, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE PEDIATRIC BRONCHOSCOPE DOESN'T GO WELL INSIDE THE ETT". AS A RESULT, THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH ANOTHER ETT. NO HARM OR INJURY TO THE PATIENT OTHER THAN RE-INTUBATION. THE PATIENT STATUS IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED ON 5 MAY 2023 STATES THAT "THE PATIENT DID NOT DESATURATE. THERE WAS NO HARM TO THE THROAT NOR THE SUPERIOR AIRWAY. THE PROBLEM WAS THE IMPOSSIBILITY TO CONFIRM PROPER POSITIONING BECAUSE THE BRONCHOSCOPE COULD NOT ENTER THE TUBE. THE PROBLEM DID NOT OCCUR DURING THE INTUBATION, BUT WHILE VERIFYING PROPER POSITIONING IN THE BRONCHUS FOR SURGERY. THEY HAD TO EXTUBATE THE PATIENTS TO CHANGE THE DBL TUBE TO BE ABLE TO ENTER THE BRONCHOSCOPE IN THE TUBE. THEREFORE, AN EXTUBATING PROCESS WAS NEEDED AND THEN REINTUBATION (UNNECESSARY IF THE PROBLEM DID NOT OCCURRED WITH THE LEFT 35 DBL TUBE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824084 ↗
• MalfunctionApr 25, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809828 ↗
• MalfunctionOct 4, 2022Material Puncture/Hole; Material Puncture/Hole

  COMPLAINT REPORTS THAT: "FEMALE PATIENT, SUBMITTED TO THORACOTOMY BY VIDEO THORACOSCOPY AND PLEURODESIS, WHERE LEFT BRONCHO-CATH TUBE #35 IS USED, WHICH FAILS DURING SURGERY. TUBE PRESENTS PERFORATION IN THE CUFF, SO A CHANGE IS REQUESTED TO PERFORM THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536628 ↗