PENTAX FB-8VRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04961333227846), received between Nov 13, 2020 and Jun 5, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465677 ↗
• MalfunctionMay 20, 2024Fluid/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 19348957 ↗
• MalfunctionFeb 29, 2024Break; 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 18805184 ↗
• MalfunctionFeb 9, 2024Fluid/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 18673814 ↗
• MalfunctionJan 24, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568178 ↗
• MalfunctionJan 12, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500888 ↗
• MalfunctionNov 7, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081699 ↗
• MalfunctionOct 17, 2023Optical 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 17947656 ↗
• MalfunctionSep 14, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752602 ↗
• MalfunctionJul 4, 2023Overcorrection; Overcorrection

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253721 ↗
• MalfunctionMay 25, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000758 ↗
• MalfunctionMay 19, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959537 ↗
• MalfunctionMay 11, 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 16909294 ↗
• MalfunctionMar 16, 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 16551120 ↗
• MalfunctionDec 9, 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 15948207 ↗
• MalfunctionNov 10, 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 15777480 ↗
• MalfunctionOct 21, 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 15645597 ↗
• MalfunctionAug 18, 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 15247078 ↗
• MalfunctionJul 28, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. DISTAL BODY DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118659 ↗
• MalfunctionJun 2, 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 14571106 ↗
• MalfunctionFeb 8, 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 13477428 ↗
• MalfunctionFeb 8, 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 13477423 ↗
• MalfunctionNov 13, 2020Failure to Disconnect; Failure to Disconnect

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 25-FEB-2020 REGARDING "BRUSH STUCK/BROKEN IN CHANNEL", INVOLVING PENTAX MEDICAL FIBER BRONCHOSCOPE, MODEL FB-8V, SERIAL NUMBER (B)(4). THE END USER STATED THAT THEY EXPERIENCED THE FAILURE DURING REPROCESSING. NO PATIENT INVOLVEMENT. THE CUSTOMER OWNED FIBERSCOPE WAS RETURNED FOR EVALUATION ON 05-MAR02020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL" AS NOTED 3 FULL AND ONE HALF BROKEN BRUSH FIBERS, CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 06-MAR-2020: PRIMARY OPERATION CHANNEL HOLE, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, INSERTION TUBE BUCKLES AT STAGE 1, SOME FUNCTIONS CANNOT BE CHECKED UNIT COMPROMISED BY FLUID, OCULAR ASSY SCRATCHED, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, INSERTION FLEXIBLE TUBE W/SEGMENT, SEGMENT STEEL BRAID, OPERATION CHANNEL, DISTAL ATTACHING PIN, BENDING RUBBER, SCREEN MASK. ON 09-NOV-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL FB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840080 ↗

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