PENTAX FB-18VRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04961333227624), received between Nov 8, 2020 and Jun 28, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 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 19630897 ↗
• MalfunctionJun 28, 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 19630890 ↗
• MalfunctionJun 26, 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 19612231 ↗
• MalfunctionMar 1, 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 18813827 ↗
• MalfunctionDec 20, 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 18361558 ↗
• MalfunctionDec 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 18298863 ↗
• MalfunctionOct 3, 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 17858452 ↗
• MalfunctionAug 29, 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 17639740 ↗
• MalfunctionJul 21, 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 17369381 ↗
• MalfunctionMay 16, 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 16936711 ↗
• MalfunctionApr 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 16748898 ↗
• MalfunctionApr 11, 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 16711350 ↗
• MalfunctionFeb 22, 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 16415363 ↗
• MalfunctionFeb 6, 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 16302237 ↗
• MalfunctionJan 19, 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 16200714 ↗
• MalfunctionDec 13, 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 15966587 ↗
• MalfunctionDec 12, 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 15957563 ↗
• MalfunctionNov 10, 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 15768195 ↗
• MalfunctionNov 6, 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 15741462 ↗
• MalfunctionSep 7, 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 15367204 ↗
• MalfunctionAug 31, 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 15332688 ↗
• MalfunctionNov 8, 2020Device Reprocessing Problem; Device Reprocessing Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED DURING PRE-PROCEDURAL INSPECTION IN THE UNITED STATES. THE REPORTED COMPLAINT RECEIVED UNDER NOTIFICATION (B)(4) FOR ACCESSORY STUCK IN SCOPE "WHITE PIECES STUCK IN DOES NOT KNOW WHAT EXACTLY IT IS", INVOLVING THE PENTAX MEDICAL FIBEROPTIC BRONCHOSCOPE, MODEL FB-18V, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO A GFE REQUEST VIA EMAIL ON 09-OCT-2020, AND STATED THE WHITE PIECES STUCK IN THE ENDOSCOPE WERE FOUND DURING THE PRE-INSPECTION CHECK AND REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER OWNED FIBEROPTIC BRONCHOSCOPE WAS RETURNED FOR EVALUATION ON 05-OCT-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN WAS UNABLE TO CONFIRM THE CUSTOMERS EXPERIENCE AND DOCUMENTED THE FOLLOWING FINDINGS ON 06-OCT-2020: IMAGE ALIGNMENT OUT, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10806329 ↗

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-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
• 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