FUJIFILM EC-530HL2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547410323856), received between Jan 23, 2018 and Jan 23, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2018Device Reprocessing Problem; Device Reprocessing Problem

  IN RESPONSE TO THE FDA INSPECTION CONDUCTED IN (B)(4) 2015, A PHASE 1 TWO YEAR RETROSPECTIVE REVIEW ((B)(4) 2013 TO (B)(4) 2015) OF ALL ENDOSCOPE SERVICE WORK ORDERS WAS PERFORMED, IN ORDER TO IDENTIFY AND ASSESS ENDOSCOPE MALFUNCTIONS THAT MAY POTENTIALLY FALL WITHIN THE MDR REPORTABILITY REGULATIONS 21 CFR 803. AS A RESULT OF THAT INITIAL PHASE 1 RETROSPECTIVE REVIEW, MDRS WERE SUBMITTED RETROSPECTIVELY. A PHASE 2 RETROSPECTIVE REVIEW FOR THE PERIOD OF (B)(4) 2015 TO (B)(4) 2016, HAS ALSO BEEN CONDUCTED. AS A RESULT OF THE PHASE 2 REVIEW, IT WAS DETERMINED THAT THE IDENTIFIED MALFUNCTION MAY RESULT IN A WORST CASE SCENARIO AS "FOREIGN MATTER RESIDUE FOUND IN SCOPE CHANNEL/PORT/VALVE CYLINDER ". HOWEVER, BECAUSE THERE IS LITTLE INFORMATION AVAILABLE ON THE UNDERLYING EVENT WHICH LED TO THE REPAIR, THE COMPANY IS UNABLE TO DETERMINE WHETHER THIS MALFUNCTION CAUSED ANY RISK TO A PATIENT. NO KNOWN PATIENT INJURY OR DEATH RESULTED FROM THIS EVENT; THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

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

  MAUDE report 7211610 ↗
• MalfunctionJan 23, 2018Mechanical Problem; Mechanical Problem

  IN RESPONSE TO THE FDA INSPECTION CONDUCTED IN (B)(6) 2015, A PHASE 1 TWO YEAR RETROSPECTIVE REVIEW ((B)(6) 2013 TO (B)(6) 2015) OF ALL ENDOSCOPE SERVICE WORK ORDERS WAS PERFORMED IN ORDER TO IDENTIFY AND ASSESS ENDOSCOPE MALFUNCTIONS THAT MAY POTENTIALLY FALL WITHIN THE MDR REPORTABILITY REGULATIONS 21 CFR 803. AS A RESULT OF THAT INITIAL PHASE 1 RETROSPECTIVE REVIEW, MDRS WERE SUBMITTED RETROSPECTIVELY. A PHASE 2 RETROSPECTIVE REVIEW FOR THE PERIOD OF (B)(6) 2015 TO (B)(6) 2016, HAS ALSO BEEN CONDUCTED. AS A RESULT OF THE PHASE 2 REVIEW, IT WAS DETERMINED THAT THE IDENTIFIED MALFUNCTION MAY TRIGGER, IN A WORST CASE SCENARIO THE "BENDING SECTION TO BECOME LOCKED IN A J-SHAPE AND CANNOT BE RELEASED". HOWEVER, BECAUSE THERE IS LIMITED INFORMATION REGARDING THE UNDERLYING EVENT WHICH LED TO THE REPAIR, THE COMPANY IS UNABLE TO DETERMINE WHETHER THE WORST CASE SCENARIO ACTUALLY OCCURRED AND CAUSED ANY RISK TO A PATIENT. NO KNOWN PATIENT INJURY OR DEATH RESULTED FROM THIS EVENT; HOWEVER, THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

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

  MAUDE report 7211581 ↗
• MalfunctionJan 23, 2018Mechanical Problem; Mechanical Problem

  IN RESPONSE TO THE FDA INSPECTION CONDUCTED IN APRIL 2015, A PHASE 1 TWO YEAR RETROSPECTIVE REVIEW (AUGUST 1, 2013 TO AUGUST 31, 2015) OF ALL ENDOSCOPE SERVICE WORK ORDERS WAS PERFORMED IN ORDER TO IDENTIFY AND ASSESS ENDOSCOPE MALFUNCTIONS THAT MAY POTENTIALLY FALL WITHIN THE MDR REPORTABILITY REGULATIONS 21 CFR 803. AS A RESULT OF THAT INITIAL PHASE 1 RETROSPECTIVE REVIEW, MDRS WERE SUBMITTED RETROSPECTIVELY. A PHASE 2 RETROSPECTIVE REVIEW FOR THE PERIOD OF SEPTEMBER 1, 2015 TO JULY 31, 2016, HAS ALSO BEEN CONDUCTED. AS A RESULT OF THE PHASE 2 REVIEW, IT WAS DETERMINED THAT THE IDENTIFIED MALFUNCTION MAY TRIGGER, IN A WORST CASE SCENARIO THE "BENDING SECTION TO BECOME LOCKED IN A J-SHAPE AND CANNOT BE RELEASED". HOWEVER, BECAUSE THERE IS LIMITED INFORMATION REGARDING THE UNDERLYING EVENT WHICH LED TO THE REPAIR, THE COMPANY IS UNABLE TO DETERMINE WHETHER THE WORST CASE SCENARIO ACTUALLY OCCURRED AND CAUSED ANY RISK TO A PATIENT. NO KNOWN PATIENT INJURY OR DEATH RESULTED FROM THIS EVENT; HOWEVER, THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

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

  MAUDE report 7211576 ↗
• MalfunctionJan 23, 2018Mechanical Problem; Mechanical Problem

  IN RESPONSE TO THE FDA INSPECTION CONDUCTED IN APRIL 2015, A PHASE 1 TWO YEAR RETROSPECTIVE REVIEW (AUGUST 1, 2013 TO AUGUST 31, 2015) OF ALL ENDOSCOPE SERVICE WORK ORDERS WAS PERFORMED IN ORDER TO IDENTIFY AND ASSESS ENDOSCOPE MALFUNCTIONS THAT MAY POTENTIALLY FALL WITHIN THE MDR REPORTABILITY REGULATIONS 21 CFR 803. AS A RESULT OF THAT INITIAL PHASE 1 RETROSPECTIVE REVIEW, MDRS WERE SUBMITTED RETROSPECTIVELY. A PHASE 2 RETROSPECTIVE REVIEW FOR THE PERIOD OF SEPTEMBER 1, 2015 TO JULY 31, 2016, HAS ALSO BEEN CONDUCTED. AS A RESULT OF THE PHASE 2 REVIEW, IT WAS DETERMINED THAT THE IDENTIFIED MALFUNCTION MAY TRIGGER, IN A WORST CASE SCENARIO THE "BENDING SECTION TO BECOME LOCKED IN A J-SHAPE AND CANNOT BE RELEASED". HOWEVER, BECAUSE THERE IS LIMITED INFORMATION REGARDING THE UNDERLYING EVENT WHICH LED TO THE REPAIR, THE COMPANY IS UNABLE TO DETERMINE WHETHER THE WORST CASE SCENARIO ACTUALLY OCCURRED AND CAUSED ANY RISK TO A PATIENT. NO KNOWN PATIENT INJURY OR DEATH RESULTED FROM THIS EVENT; HOWEVER, THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

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

  MAUDE report 7211575 ↗
• MalfunctionJan 23, 2018Mechanical Problem; Mechanical Problem

  IN RESPONSE TO THE FDA INSPECTION CONDUCTED IN APRIL 2015, A PHASE 1 TWO YEAR RETROSPECTIVE REVIEW (AUGUST 1, 2013 TO AUGUST 31, 2015) OF ALL ENDOSCOPE SERVICE WORK ORDERS WAS PERFORMED IN ORDER TO IDENTIFY AND ASSESS ENDOSCOPE MALFUNCTIONS THAT MAY POTENTIALLY FALL WITHIN THE MDR REPORTABILITY REGULATIONS 21 CFR 803. AS A RESULT OF THAT INITIAL PHASE 1 RETROSPECTIVE REVIEW, MDRS WERE SUBMITTED RETROSPECTIVELY. A PHASE 2 RETROSPECTIVE REVIEW FOR THE PERIOD OF SEPTEMBER 1, 2015 TO JULY 31, 2016, HAS ALSO BEEN CONDUCTED. AS A RESULT OF THE PHASE 2 REVIEW, IT WAS DETERMINED THAT THE IDENTIFIED MALFUNCTION MAY TRIGGER, IN A WORST CASE SCENARIO THE "BENDING SECTION TO BECOME LOCKED IN A J-SHAPE AND CANNOT BE RELEASED". HOWEVER, BECAUSE THERE IS LIMITED INFORMATION REGARDING THE UNDERLYING EVENT WHICH LED TO THE REPAIR, THE COMPANY IS UNABLE TO DETERMINE WHETHER THE WORST CASE SCENARIO ACTUALLY OCCURRED AND CAUSED ANY RISK TO A PATIENT. NO KNOWN PATIENT INJURY OR DEATH RESULTED FROM THIS EVENT; HOWEVER, THIS MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

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

  MAUDE report 7211569 ↗