PENTAX FB-19TVRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04961333227655), received between Jul 16, 2021 and Jan 25, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2024Obstruction 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 18577307 ↗
• MalfunctionJan 25, 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 18577296 ↗
• MalfunctionSep 1, 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 17668267 ↗
• MalfunctionMar 28, 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 16625578 ↗
• MalfunctionFeb 13, 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 16360476 ↗
• 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 16049108 ↗
• MalfunctionSep 30, 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 15516195 ↗
• MalfunctionJun 23, 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 14784357 ↗
• MalfunctionJun 22, 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 14767939 ↗
• MalfunctionJul 24, 2021Fluid/Blood Leak; Loose or Intermittent Connection; Material Split, Cut or Torn; Fluid/Blood Leak; Loose or Intermittent Connection; Material Split, Cut or Torn

  THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. SIDE COVER LEAKY, ANGULATION LEVER LOOSENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222543 ↗
• MalfunctionJul 16, 2021Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. OPERATION CHANNEL BUCKLED AT 60 CM, LEAKY. SOLD DATE 2020-02-27, LAST MAJOR REPAIR 2020-07-31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178902 ↗