FUJIFILM PB2020-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410343052), received between Mar 31, 2021 and Aug 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON AUGUST 11, 2022, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLVING PB2020-M. IT WAS REPORTED THAT DURING A DIAGNOSTIC STUDY THE TIP OF THE SUBJECT PROBE CAME APART WHILE INSIDE THE PATIENT. THE PROBE PIECE COULD NOT BE SEEN ON THE SCOPE IMAGE AND WAS UNABLE TO BE REMOVED, AND THE STUDY COULD NOT BE COMPLETED. THERE WAS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15292634 ↗
• MalfunctionMar 31, 2021Crack; Device Contamination with Body Fluid; Crack; Device Contamination with Body Fluid

  ON (B)(6) 2021, FUJIFILM CORPORATION WAS INFORMED OF AN ISSUE WITH ITS PB2020-M MINIPROBE. DURING A ROBOTIC BRONCHOSCOPY PROCEDURE, THE PROBE APPEARED TO BE DIFFICULT TO ADVANCE AT TIMES. HOWEVER, THE PROCEDURE WAS COMPLETED WITHOUT REQUIRING EXCESSIVE FORCE. THE PATIENT WAS UNHARMED, AND NO ADVERSE EVENT OCCURRED. THE PROBE HAD NOT BEEN USED PRIOR TO THIS PROCEDURE. FOLLOWING THE PROCEDURE, THE MINIPROBE WAS INSPECTED; BLOOD WAS FOUND INSIDE THE PROBE AND A CRACK IN THE DISTAL TIP WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11598728 ↗