FUJIFILM EB-530TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547410330151), received between Jan 11, 2018 and Jan 2, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2024Break; Fracture; Break; Fracture

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EB-530T. IT WAS REPORTED THAT THE LENS IS BROKEN. IN ADDITION, AIRWAY ENDO TRACHEAL TUBE BECAME CLOGGED WITH BLOOD. ENDOTRACHEAL TUBE CHANGED WITH A 7.5 SIZE. PROVIDER FORCED SCOPE IN A TUBE THAT WAS TOO SMALL.

  Patient problems: Airway Obstruction; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18431995 ↗
• MalfunctionJan 11, 2018Microbial Contamination of Device; Contamination /Decontamination Problem; Microbial Contamination of Device; Contamination /Decontamination Problem

  FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) WAS INFORMED ON OCTOBER 25, 2017 BY A SERVICE PARTNER THAT A HOSPITAL HAD EXPERIENCED SEVERAL PSEUDOMONAS INFECTIONS IN THEIR RESPIRATORY DEPARTMENT AND THE DOCTORS WERE CONCERNED THEY COULD BE FROM ENDOSCOPES, ALTHOUGH THE SOURCE OF THE INFECTION HAD NOT BEEN DETERMINED. FUJIFILM ATTEMPTED TO CONTACT THE HOSPITAL AT THAT TIME, BUT THE HOSPITAL DID NOT RESPOND TO THE INQUIRY. ON (B)(6) 2017, FMSU WAS INFORMED BY SERVICE PARTNER THAT THERE WAS A SECOND INCIDENT OF A CERTAIN FUJIFILM BRONCHOSCOPE BEING USED RESULTING IN POSITIVE PATIENT BAL SAMPLE. ON JANUARY 5, 2018 FMSU WAS INFORMED BY THE HOSPITAL THAT ENDOSCOPE EB530T 1B084G148 WAS NOT INVOLVED IN THE SECOND INCIDENT REPORTED ON (B)(6) 2017 BUT WAS THE SUBJECT SCOPE REPORTED ON (B)(6) 2017. ENDOSCOPE EB530T 1B084G148 WAS USED ON (B)(6) 2017 TO OBTAIN PATIENT BAL SAMPLES WHICH RESULTED IN POSITIVE PSEUDOMONAS CULTURES. IN ADDITION, THE SCOPE EB530T 1B084G148 WAS NOTED TO HAVE EXCESSIVE AMOUNT OF FLUID COMING FROM SUCTION CHANNEL WHEN PROCESSING THE ENDOSCOPE, THEREFORE IT WAS REMOVED FROM SERVICE ON OR AROUND (B)(6) AND WAS THEN SENT TO A FUJIFILM AUTHORIZED SERVICE FACILITY FOR INSPECT

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7184539 ↗
• MalfunctionJan 11, 2018Microbial Contamination of Device; Contamination /Decontamination Problem; Microbial Contamination of Device; Contamination /Decontamination Problem

  FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) WAS INFORMED ON OCTOBER 25, 2017 BY A SERVICE PARTNER THAT A HOSPITAL HAD EXPERIENCED SEVERAL PSEUDOMONAS INFECTIONS IN THEIR RESPIRATORY DEPARTMENT AND THE DOCTORS WERE CONCERNED THEY COULD BE FROM ENDOSCOPES, ALTHOUGH THE SOURCE OF THE INFECTION HAD NOT BEEN DETERMINED. FUJIFILM ATTEMPTED TO CONTACT THE HOSPITAL AT THAT TIME, BUT THE HOSPITAL DID NOT RESPOND TO THE INQUIRY. ON DECEMBER 12, 2017, FMSU WAS INFORMED BY A SERVICE PARTNER THAT THE HOSPITAL HAD USED THE ENDOSCOPE (EB530T SERIAL (B)(4)) TO OBTAIN PATIENT BAL SAMPLES WHICH RESULTED IN POSITIVE PSEUDOMONAS CULTURES. THE FIRST INSTANCE OF THE SUBJECT ENDOSCOPE SCOPE BAL SAMPLE RESULTING POSITIVE OCCURRED ON (B)(6) 2017. DURING THE (B)(6) EPISODE THE ENDOSCOPE WAS SUBSEQUENTLY TESTED FOR CONTAMINANTS AND RESULTED POSITIVE FOR PSEUDOMONAS. THE SUBJECT ENDOSCOPE WAS THEN SENT TO A FUJIFILM AUTHORIZED SERVICE FACILITY FOR INSPECTION AND REPAIR. THE SERVICE FACILITY COMPLETED THE REPAIR AND RETURNED THE SCOPE TO THE HOSPITAL ON NOVEMBER 29, 2017. THE ENDOSCOPE WAS REPROCESSED AND ON (B)(6) 2017, WAS USED AND RESULTED IN POSITIVE PATIENT BAL SAMPLES FOR PSEUDOMONAS. ALTHOUGH POSITIVE

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7182043 ↗