FUJIFILM ED-530XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547410330915), received between Nov 27, 2017 and Oct 14, 2019 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2019Microbial Contamination of Device; Microbial Contamination of Device

  ON (B)(6) 2019 FUJIFILM CORPORATION WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS CULTURED AND TESTED POSITIVE FOR UNSPECIFIED MICROORGANISM (< 10CFU). AS THE SUBJECT UNIT WAS BEING SAMPLED AND CULTURED AS PART OF A POSTMARKET SURVEILLANCE ACTIVITY, NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. PER STUDY PROTOCOL, THE ENDOSCOPE WAS IMMEDIATELY QUARANTINED AFTER INITIAL SAMPLING, UNTIL CULTURING DATA WERE AVAILABLE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THE ENDOSCOPE WAS REQUESTED FOR RETURN FOR INSTRUMENT INSPECTION/EVALUATION BY FUJIFILM MEDICAL SYSTEMS USA (FMSU). THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Patient Involvement

  MAUDE report 9188840 ↗
• MalfunctionSep 19, 2019Microbial Contamination of Device; Microbial Contamination of Device

  ON 22 AUG 2019 FUJIFILM CORPORATION WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS CULTURED AND TESTED POSITIVE FOR SHIGELLA FLEXNERI. AS THE SUBJECT UNIT WAS BEING SAMPLED AND CULTURED AS PART OF A POSTMARKET SURVEILLANCE ACTIVITY, NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. PER STUDY PROTOCOL, THE ENDOSCOPE WAS IMMEDIATELY QUARANTINED AFTER INITIAL SAMPLING, UNTIL CULTURING DATA WERE AVAILABLE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THE ADDITIONAL SAMPLING AND CULTURING WAS PERFORMED AFTER THE SECOND DISINFECTION, AND CONFIRMED THAT NO HIGH CONCERN ORGANISMS WERE PRESENT. THE ENDOSCOPE WAS SENT BACK TO FUJIFILM FOR INSTRUMENT INSPECTION/EVALUATION BY FUJIFILM MEDICAL SYSTEMS USA (FMSU); NO DEVICE FAILURE WAS CONFIRMED IN THE AREA THE CULTURE WAS PERFORMED.

  Patient problems: No Patient Involvement

  MAUDE report 9088406 ↗
• MalfunctionApr 22, 2019Microbial Contamination of Device; Microbial Contamination of Device

  FUJIFILM WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS CULTURED AND TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE. AS THE SUBJECT UNIT WAS BEING SAMPLED AND CULTURED AS PART OF A POSTMARKET SURVEILLANCE ACTIVITY, NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. PER STUDY PROTOCOL, THE ENDOSCOPE WAS IMMEDIATELY QUARANTINED AFTER INITIAL SAMPLING, UNTIL CULTURING DATA WERE AVAILABLE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THE ADDITIONAL SAMPLING AND CULTURING WAS PERFORMED AFTER THE SECOND DISINFECTION, AND CONFIRMED THAT NO HIGH CONCERN ORGANISM WERE PRESENT. THE ENDOSCOPE WAS SENT BACK TO FUJIFILM FOR INSTRUMENT INSPECTION/EVALUATION BY FUJIFILM MEDICAL SYSTEMS USA (FMSU); NO. DEVICE FAILURE WAS CONFIRMED.

  Patient problems: No Patient Involvement

  MAUDE report 8536398 ↗
• DeathNov 27, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Missing Value Reason

  ON (B)(4) 2017 THE MANUFACTURER (FUJIFILM CORPORATION) BECAME AWARE OF THE ALLEGED EVENT. THE NOTIFICATION INDICATED A POTENTIAL CLAIM AGAINST FUJIFILM, STEMMING FROM A DEATH ALLEGEDLY RELATED TO A FUJIFILM DUODENOSCOPE MODEL ED-530XT, USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015, AT (B)(6). WE HAVE NOT YET BEEN ABLE TO CONFIRM, HOWEVER, WHETHER A FUJIFILM DUODENOSCOPE MODEL ED-530XT WAS EVEN USED DURING THE PROCEDURE. THE FIRM IS WAITING TO RECEIVE MEDICAL RECORDS OF THE PATIENT TO CONDUCT FURTHER INVESTIGATION.

  Patient problems: Death; Sepsis

  MAUDE report 7060136 ↗
• DeathNov 27, 2017Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2017 THE IMPORTER ((B)(4)) BECAME AWARE OF THE ALLEGED EVENT. THE NOTIFICATION INDICATED A POTENTIAL CLAIM AGAINST FUJIFILM, STEMMING FROM A DEATH ALLEGEDLY RELATED TO A FUJIFILM DUODENOSCOPE MODEL ED-530XT, USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015, AT (B)(6). WE HAVE NOT YET BEEN ABLE TO CONFIRM, HOWEVER, WHETHER A FUJIFILM DUODENOSCOPE MODEL ED-530XT WAS EVEN USED DURING THE PROCEDURE. THE FIRM IS WAITING TO RECEIVE MEDICAL RECORDS OF THE PATIENT TO CONDUCT FURTHER INVESTIGATION.

  Patient problems: Death

  MAUDE report 7060130 ↗