FUJIFILM EG-760RRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04547410358667), received between Jun 17, 2021 and Apr 17, 2026 — classified as 5 injuries, 6 malfunctions.

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

• MalfunctionApr 17, 2026Crack; Material Split, Cut or Torn

  ON 03/19/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING EG-760R. IT WAS REPORTED THAT THE POLYPS KEEP GETTING STUCK IN THE CHANNEL AND THE CUSTOMER HAS TO KEEP SUCTIONING AND PULLING OUT THE FORCEPS. DUE TO UNKNOWN PATIENT STATUS, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. THE EVALUATION OF THE PRODUCT CONFIRMED THAT THE FORCEPS CHANNEL TUBE WAS DAMAGED IN BENDING SECTION. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 24911156 ↗
• InjuryApr 25, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSERTION TUBE WAS FOUND TO BE PEELING, AND DIFFICULTY WAS ENCOUNTERED IN PASSING THE SNARE THROUGH THE SCOPE. EVENTUALLY, THE SNARE PASSED THROUGH AND A PIECE OF PLASTIC WAS DISCOVERED AND RETRIEVED USING A ROTH NET. ALTHOUGH THE PLASTIC MATERIAL IS BIOLOGICALLY SAFE AND POSES NO HEALTH RISK, THE RETRIEVAL CREATED AN UNPLANNED MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908224 ↗
• InjuryFeb 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A ENDOSCOPIC PROCEDURE, AN ENDO CLIP ACCIDENTLY DEPLOYED INTO THE SCOPE TO CONTROL A BLEED. THE CLIP WAS LATER RETRIEVED DURING MANUAL CLEANING. THIS DELAYED THE PROCEDURE BY THREE MINUTES WHILE THE SCOPE WAS REPLACED. THE PATIENT WHO HAD BLEEDING AFTER A BIOPSY FROM THE GASTRIC BODY, WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER EVALUATION. THE SCREEN WAS RED AND WOULD NOT CLEAR DESPITE USING "WINDOW WASHING" RESULTING TO INABILITY TO SEE DURING CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21397450 ↗
• InjuryMay 1, 2024Device Handling Problem; Device Handling Problem

  ON APRIL 5TH, 2024, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-760R. IT WAS REPORTED THAT A SMALL FRAGMENT OF PLASTIC FELL OUT INTO THE PATIENT FROM THE INNER CHANNEL OF THE SCOPE WHEN SNARE WAS UTILIZED. PLASTIC WAS RETRIEVED AND ISOLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219655 ↗
• InjuryApr 4, 2024Scratched Material; Scratched Material

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-760R. IT WAS REPORTED THAT A SMALL FRAGMENT OF PLASTIC FELL OUT INTO THE PATIENT FROM THE INNER CHANNEL OF THE SCOPE WHEN SNARE WAS UTILIZED. PLASTIC WAS RETRIEVED AND ISOLATED. INCIDENT REPORT COMPLETED AND SCOPE TAKEN OUT OF SERVICE. NO OTHER INFORMATION PROVIDED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047044 ↗
• InjuryMar 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON FEBRUARY 21, 2024, FUJIFILM CORPORATION BECAME AWARE OF A COMPLAINT INVOLVING EG-760R. THE CUSTOMER FOUND OUT THE FIRST BALLOON DILATOR WOULD NOT PASS DURING PROCEDURE (UPPER ENDOSCOPY), READY TO DILATE. THE SECOND BALLOON DILATOR PASSED AND THAT IS WHEN BLACK PLASTIC PIECE NOTICED IN PATIENT ESOPHAGUS. BLACK PIECE WAS THEN REMOVED FROM THE PATIENT BODY AND THEN PASSED THE BALLOON DILATOR AGAIN AND DILATED THE PATIENT ESOPHAGUS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948359 ↗
• MalfunctionJan 29, 2024Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  ON JANUARY 9TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-760R. IT WAS REPORTED THAT FOREIGN DEBRIS CAME OUT OF THE CHANNEL DURING THE PROCEDURE. IT WAS UNCERTAIN WHAT CAME OUT OF ACCESSORY CHANNEL AFTER EXPERIENCING TENSION WHEN BIOPSY FORCEPS WERE PASSED THROUGH. THE PHYSICIAN ATTEMPTED TO TAKE ROUTINE BIOPSY FROM DUODENUM WHEN HE EXPERIENCED TENSION GETTING FORCEPS OUT OF THE ACCESSORY CHANNEL, ANOTHER BIOPSY FORCEPS WAS OPENED AND UPON FURTHER PUSH, BOTH TECHNICIAN AND PHYSICIAN NOTICED DEBRIS COMING OUT. THEY WERE ONLY ABLE TO TAKE PICTURE OF IT BUT UNABLE TO RETRIEVE "FOREIGN DEBRIS". AS SUCH, THIS REPORT IS BEING SUBMITTED IN DUE TO UNKNOWN IMPACT OF DEBRIS AND THE INABILITY TO RETRIEVE DEBRIS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602647 ↗
• MalfunctionNov 29, 2023Leak/Splash; Dent in Material; Leak/Splash; Dent in Material

  ON OCTOBER 31ST, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-760R. . IT WAS REPORTED THAT THE SCOPE HAS A BUCKLE OR GOUGE IN THE DISTAL WORKING CHANNEL. THERE IS ALSO A LEAK IN THE WORKING CHANNEL DISCOVERED UPON INSEPCTION. A SECOND AIR LEAK TEST WAS PERFORMED AND THE DAMAGE WAS CONFIRMED ON THE BORESCOPE INSPECTION. THE DAMAGE TO THE WORKING CHANNEL WAS SUSPECTED DURING A BALLOON DIALATION. THE MD COULD NOT GET THE BALLOON TO ADVANCE OUT OF THE DISTAL TIP OF THE SCOPE. ANOTHER SCOPE AND ANOTHER BALLOON HAD TO BE RETRIEVED AS THE BALLOON GOT BENT UP IN THE DAMAGED SCOPE. THE PATIENT SPENT MORE TIME UNDER ANESTHESIA AS ANOTHER SCOPE HAD TO BE RETRIEVED AND ANOTHER BALLOON HAD TO BE OPENED AND PREPPED IN ANOTHER ROOM. DUE TO EXTEND TIME UNDER ANESTHESIA, THE REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234798 ↗
• MalfunctionNov 27, 2023Failure to Disinfect; Failure to Disinfect

  ON OCTOBER 26TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-760R. THE AUTOMATED ENDOSCOPE REPROCESSOR FAILED 9 OF THE 10 CYCLES, STATING THE AIR CHANNEL WAS BLOCKED. ON OCTOBER 20TH, 2023, THE SCOPE FAILED 3 TIMES WITH THE AIR CHANNEL BLOCKED AND FINALLY PASSED ON THE 4TH TIME. ON OCTOBER 23, 2023, THE SCOPE FAILED 6 TIMES WITH THE SAME ISSUE, UNABLE TO PASS THE AER AT ALL. THE BLOCKS, BASINS, AND AER WERE SWITCHED AND THE SCOPE WOULD NOT PASS. IT IS UNKNOWN WHAT PART OF THE SCOPE HAD AN ISSUE. THERE WERE NO ORGANISMS IDENTIFIED. THE SCOPE PASSED THE CHANNEL CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212122 ↗
• MalfunctionAug 12, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2021, FUJIFILM CORPORATION WAS INFORMED OF AN INCIDENT INVOLVING THE EG-760R GASTROSCOPE. DURING THE BEGINNING OF AN EGD PROCEDURE, THE DOCTOR PUSHED BIOPSY FORCEPS THROUGH A CHANNEL AND FELT RESISTANCE. AS SOON AS THE DOCTOR WAS ABLE TO GET THROUGH, A PIECE OF PLASTIC CAME OUT. THE FOREIGN OBJECT APPEARS TO BE A PIECE OF PLASTIC, HOWEVER IT WAS NOT CONFIRMED. IT WAS CONFIRMED THAT THE DOCTOR PROCEEDED TO USE THE SCOPE AND WAS ABLE TO COMPLETE TO PROCEDURE. THERE WAS NO INJURY OR ADVERSE EVENT THAT OCCURRED TO THE PATIENT. AFTER COMPLETION THE SCOPE WAS REPROCESSED AND REMOVED FROM SERVICE. THERE WAS NO PATIENT IMPACT, INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312798 ↗
• MalfunctionJun 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2021, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. WAS INFORMED OF AN INCIDENT INVOLVING THE (B)(4) GASTROSCOPE. DURING REPROCESSING OF THE SCOPE, A BROKEN PIECE OF A CLEANING BRUSH WAS FOUND IN THE BIOPSY PORT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS TESTED FOR POSSIBLE CROSS-CONTAMINATION, AND THE TEST RESULTS CAME BACK NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016388 ↗