PENTAX FB-18RBSRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04961333224098), received between Jul 21, 2022 and Jun 19, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K951199); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Optical Distortion; Optical Distortion

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (CLOUDY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564813 ↗
• MalfunctionJan 15, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510047 ↗
• MalfunctionNov 9, 2023Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098115 ↗
• MalfunctionOct 27, 2023Obstruction of Flow; Obstruction of Flow

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017530 ↗
• MalfunctionOct 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928728 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841010 ↗
• MalfunctionJul 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347973 ↗
• MalfunctionJun 11, 2023Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102610 ↗
• MalfunctionApr 25, 2023Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16804511 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596257 ↗
• MalfunctionJan 19, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16201174 ↗
• MalfunctionDec 27, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049171 ↗
• MalfunctionDec 5, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913075 ↗
• MalfunctionSep 7, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15367874 ↗
• MalfunctionJul 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127592 ↗
• MalfunctionJul 21, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071301 ↗
• MalfunctionJul 21, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071299 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951199. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2016 · Apr 6, 2016 · Terminated
  Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
• Z-2076-2016 · Apr 6, 2016 · Terminated
  Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org