FUJIFILM ED-580XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04547410359282), received between Jan 29, 2020 and Mar 13, 2026 — classified as 21 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Microbial Contamination of Device

  THE FACILITY REPORTED THAT CULTURE TESTS CONDUCTED AFTER REPAIRS ON TWO ENDOSCOPES (SERIAL NUMBERS (B)(6) OWNED BY THE FACILITY FAILED. THE DETAILS ARE AS FOLLOWS: ON (B)(6) 2025, (B)(6) REPAIR COMPLETED, ON (B)(6) 2025, (B)(6) REPAIR COMPLETED, ON (B)(6) 2025, (B)(6) CULTURE TESTS PASSED, ON (B)(6) 2026, (B)(6) CULTURE TESTS FAILED. AFTER THE CULTURE TEST CONDUCTED ON (B)(6) 2026, THE SUBJECT ENDOSCOPES WERE NOT USED CLINICALLY, AND NO REPORTS OF HEALTH HAZARDS SUCH AS INFECTION HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596814 ↗
• MalfunctionMar 13, 2026Microbial Contamination of Device

  THE FACILITY REPORTED THAT CULTURE TESTS CONDUCTED AFTER REPAIRS ON TWO ENDOSCOPES (SERIAL NUMBERS (B)(6) OWNED BY THE FACILITY FAILED. THE DETAILS ARE AS FOLLOWS: ON (B)(6) 2025, (B)(6) REPAIR COMPLETED, ON (B)(6) 2025, (B)(6) REPAIR COMPLETED, ON (B)(6) 2025, (B)(6) CULTURE TESTS PASSED, ON (B)(6) 2026, (B)(6) CULTURE TESTS FAILED. AFTER THE CULTURE TEST CONDUCTED ON (B)(6) 2026, THE SUBJECT ENDOSCOPES WERE NOT USED CLINICALLY, AND NO REPORTS OF HEALTH HAZARDS SUCH AS INFECTION HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588398 ↗
• InjuryMay 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON APRIL 30TH, 2025, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-740UT. THE ED-580XT ENDOSCOPE SHOWS NO VISIBLE DAMAGE OR FUNCTIONAL ISSUES DURING THE INITIAL INSPECTION. HOWEVER, IT HAS BEEN FLAGGED FOR FURTHER EVALUATION DUE TO A SUSPECTED INFECTION IN A PATIENT AFTER ITS USE. AS A SAFETY PRECAUTION, THE SCOPE HAS BEEN QUARANTINED. THE SUSPECTED SCOPE HAS UNDERGONE ATP TESTING WITH ADDITIONAL HLD (HIGH-LEVEL DISINFECTION) CLEANING.

  Patient problems: Unspecified Infection

  MAUDE report 22103331 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 18TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-740UT. THE ED-580XT ENDOSCOPE SHOWS NO VISIBLE DAMAGE OR FUNCTIONAL ISSUES DURING THE INITIAL INSPECTION. HOWEVER, IT HAS BEEN FLAGGED FOR FURTHER EVALUATION DUE TO A SUSPECTED INFECTION IN A PATIENT AFTER ITS USE. AS A SAFETY PRECAUTION, THE SCOPE HAS BEEN QUARANTINED. THE SUSPECTED SCOPE HAS UNDERGONE ATP TESTING WITH ADDITIONAL HLD (HIGH-LEVEL DISINFECTION) CLEANING. IMPORTER MDR IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION SINCE THE INVESTIGATION IS STILL ONGOING AT THE CUSTOMER SITE AND HAVE NOT PROVIDED THEIR RESULT.

  Patient problems: Insufficient Information

  MAUDE report 22038836 ↗
• InjuryFeb 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ELEVATOR IS NOT GIVING FULL RANGE OF MOTION (STUCK). SCARRING OF THE ESOPHAGUS OCCURRED WITH TWO PATIENTS WHEN INSERTING/REMOVING THE SCOPE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21310540 ↗
• InjuryFeb 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ELEVATOR IS NOT GIVING FULL RANGE OF MOTION (STUCK). SCARRING OF THE ESOPHAGUS OCCURRED WITH TWO PATIENTS WHEN INSERTING/REMOVING THE SCOPE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21310539 ↗
• InjuryJan 10, 2025Mechanical Jam; Mechanical Jam

  ON DECEMBER 20TH, 2024, THE FUJIFILM AMERICAS HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING SCARRING OF THE ESOPHAGUS OCCURRED WITH TWO PATIENTS, WHEN INSERTING / REMOVING THE SCOPE. THE ELEVATOR IS NOT GIVING FULL RANGE OF MOTION (STUCK). DURING THE INITIAL INVESTIGATION FUJIFILM ENGINEER FOUND THE ELEVATOR DOSE HAVE SOME TENSION WHEN ENGAGING THE LEVER, IT'S VERY MILD BUT CAN SEE WHERE THE CUSTOMER MAY HAVE A CONCERN WHEN USING THE SCOPES ELEVATOR FUNCTION. ENGINEER SUGGESTS REMOVING SOME TENSION OF THE ELEVATOR LEVER, SO THE KNOB WON'T SEEM AS TIGHT PER THEIR REQUEST. THE SCOPE FUNCTIONS WITHIN THE TOLERANCES RANGE AND MASSEURS AT 65 DEGREES (ELEVATOR). NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER.

  Patient problems: Laceration(s) of Esophagus; Scar Tissue

  MAUDE report 21125665 ↗
• MalfunctionSep 20, 2024Mechanical Jam; Mechanical Jam

  ON AUGUST 21TH 2024 FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT A STENT PREVIOUSLY STUCK IN CHANNEL, CAME OUT IN PATIENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THERE WAS NO DELAY. PROCEDURE WAS ABLE TO FINISH. A STENT FELL INTO THE PATIENT STOMACH AND IT WAS RETREIVED AFTER TWO WEEKS. FUJIFILM CORPORATION CONDUCTED ADDITIONAL HEARINGS AT THE FACILITY AND RECONFIRMED THE INCIDENT. A STENT USED DURING THE SUBJECT PROCEDURE BECAME STUCK INSIDE THE ENDOSCOPE'S CHANNEL, SO THE ENDOSCOPE WAS REMOVED FROM THE PATIENT IN THAT STATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO OTHER ADVERSE EFFECTS ON THE PATIENT. THE STENT THAT HAD BECOME STUCK INSIDE THE ENDOSCOPE'S CHANNEL WAS REMOVED TWO WEEKS LATER AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264156 ↗
• MalfunctionSep 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON AUGUST 15TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT A STENT PREVIOUSLY STUCK IN CHANNEL, CAME OUT IN PATIENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THERE WAS NO DELAY. PROCEDURE WAS ABLE TO FINISH. A STENT FELL INTO THE PATIENT STOMACH AND IT WAS RETRIEVED AFTER TWO WEEKS. NO OTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216577 ↗
• InjuryJul 18, 2024Material Puncture/Hole; Material Puncture/Hole

  ON JUNE 26TH, 2024, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT METAL OBJECTS WERE PULLED THROUGH DURING A DIAGNOSTIC PROCEDURE. THE PATIENT HAD A METAL STENT STUCK/IMPACTED AND OBSTRUCTING THEIR BILE DUCT THAT NEEDED TO BE CUT AND BROKEN INTO PIECES IN ORDER TO BE REMOVED. DUE TO THIS PATIENTS DIFFICULT ALTERED ANATOMY IT WASN'T FEASIBLE TO REMOVE THE SCOPE MULTIPLE TIMES FROM THE PATIENT AND REMOVE THE METAL PIECES WITHOUT PULLING THEM THROUGH THE CHANNEL AND RISKING DAMAGING THE SCOPE. THE METAL OBJECT WHICH WAS INVOLVED, THAT WAS 'LITTLE PIECES OF METAL WIRE FROM THE BROKEN BILIARY STENT. THE SCOPE DID NOT MALFUNCTION, IT WORKED WELL DURING THE ENTIRE PROCEDURE. PATIENT WAS NORMAL STATE OF HEALTH. PROCEDURE WAS ABLE TO FINISH SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773288 ↗
• MalfunctionJun 28, 2024Microbial Contamination of Device; Microbial Contamination of Device

  ON MAY 29TH, 2024, FUJIFILM CORPORATION BECAME AWARE OF A COMPLAINT INVOLVING ED-580XT. IT WAS REPORTED THAT QA POSITIVE CULTURE WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT. THE FACILITY PERFORMS ROUTINE CULTURE TESTING EVERY 30 DAYS. A SAMPLE OBTAINED ON MAY 3RD, 2024 WAS CULTURE TESTED AND ON MAY 7TH, 2024, PSEUDOMONAS AERUGINOSA WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631244 ↗
• InjuryApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, AND DURING THE WITHDRAWAL OF THE DUODENOSCOPE ED-580XT FROM THE PATIENT'S BODY, THE DISTAL END CAP DC-08D FELL OFF INTO THE PATIENT'S MOUTH. AFTER THE PROCEDURE, THE PROCEDURE NURSE INFORMED DOCTOR ABOUT THE DISTAL END CAP WAS MISSING WHILE DOING THE BEDSIDE CLEANING OF THE DUODENOSCOPE. THE DOCTOR WENT BACK TO CHECK ON THE PATIENT'S MOUTH AND REMOVED THE DISTAL END CAP WITH GLOVED HAND. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19161833 ↗
• InjuryMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON FEBRUARY 5TH, 2024, FUJIFILM CORPORATION BECAME AWARE OF A COMPLAINT INVOLVING DC-08D. IT WAS REPORTED THAT THE PATIENT WAS IN FOR AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WITH LASER LITHOTRIPSY. UPON COMPLETION OF PROCEDURE WHEN SCOPE WAS WITHDRAWN, DISTAL END ATTACHMENT WAS NOTED TO BE MISSING FROM SCOPE. DOCTOR AND ANESTHESIA AWARE. PATIENT TRANSFERRED TO RECOVERY CARE AREA. PATIENT REMAINED DROWSY FOR EXTENDED LENGTH OF TIME DUE TO ANESTHESIA FOR LONG PROCEDURE. ABOUT 45 MINUTES AFTER ARRIVING TO RECOVERY, STILL DROWSY, PATIENT COUGHED UP DISTAL END ATTACHMENT, PATIENT'S FAMILY MEMBER DISCOVERED AND BROUGHT TO NURSE'S ATTENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18843808 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE PATIENT HAD A TEAR/PERFORMATION AFTER ATTEMPTING TO PASS SCOPE THROUGH THE ESOPHAGUS. THE DOCTOR NOTED THAT HE IS ACCUSTOMED TO USING THE OLYMPUS SCOPES. RECENTLY DURING THE PROCEDURE, HE PERFORATED THE ESOPHAGUS ((THROUGH AND THROUGH). HE INDICATED THERE WAS RESISTANCE BEFORE THE SCOPE WAS PUSHED FURTHER AND HE IMMEDIATELY USED A EGD SCOPE TO INSPECT. THE PATIENT REQUIRED ADDITIONAL PROCEDURE AND PLACEMENT OF STENT. THERE IS NO PATIENT DEATH ASSOCIATED WITH THE EVENT.

  Patient problems: Perforation of Esophagus

  MAUDE report 17690457 ↗
• InjuryAug 31, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE PATIENT HAD A TEAR/PERFORMATION AFTER ATTEMPTING TO PASS SCOPE THROUGH THE ESOPHAGUS. THE DOCTOR NOTED THAT HE IS ACCUSTOMED TO USING THE OLYMPUS SCOPES. RECENTLY DURING THE PROCEDURE, HE PERFORATED THE ESOPHAGUS ((THROUGH AND THROUGH). HE INDICATED THERE WAS RESISTANCE BEFORE THE SCOPE WAS PUSHED FURTHER AND HE IMMEDIATELY USED A EGD SCOPE TO INSPECT. THE PATIENT REQUIRED ADDITIONAL PROCEDURE AND PLACEMENT OF STENT. PATIENT REMAINED STABLE THROUGHOUT REST OF HOSPITAL STAY AND HAS BEEN DISCHARGED TO SKILLED NURSING FACILITY.

  Patient problems: Perforation of Esophagus

  MAUDE report 17666899 ↗
• MalfunctionJun 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON MAY 31, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE SCOPE FAILED CULTURE TESTING THREE TIMES. THERE IS NO PATIENT INVOLVEMENT, DEATH, OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216923 ↗
• MalfunctionJun 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON JUNE 1, 2023, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE SCOPE FAILED CULTURE TESTING THREE TIMES. THERE IS NO PATIENT INVOLVEMENT, DEATH, OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17212936 ↗
• MalfunctionJun 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON JUNE 2, 2023, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE SCOPE CONTINUOUSLY FAILED WEEKLY CULTURES. THERE IS NO PATIENT INVOLVEMENT, DEATH, OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208476 ↗
• MalfunctionJun 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON APRIL 20, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT THE SCOPE CONTINUOUSLY FAILED WEEKLY CULTURES. THE SCOPE WAS LOST BY THE COURIER SERVICE AND WAS UNABLE TO BE INSPECTED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. HOWEVER, DUE TO THE RESULT OF FUJIFILM CORPORATION'S FINAL INVESTIGATION OF THE INCIDENT, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186498 ↗
• MalfunctionJul 8, 2022Fluid/Blood Leak

  CURRENT LEAKAGE FROM DEVICE DURING SPHINCTEROTOMY RESULTING IN INJURY TO THE DUODENAL WALL AND RESULTING IN EXCESS COAGULATION TO THE MAJOR PAPILLA THUS RAISING THE RISK OF POST-ERCP PANCREATITIS.

  Patient problems: Perforation

  MAUDE report 14955881 ↗
• MalfunctionApr 27, 2022Improper or Incorrect Procedure or Method; Electrical Shorting; Improper or Incorrect Procedure or Method; Electrical Shorting

  ON (B)(6) 2022, FUJIFILM CORPORATION WAS INFORMED OF AN INCIDENT THAT OCCURRED DURING AN ERCP PROCEDURE INVOLVING ED-580XT. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPHINCTEROTOMY, THE SUBJECT SCOPE CUT RIGHT AND BURNED THE DUODENUM. THE PERFORMING PHYSICIAN STATED THAT LEAKAGE FROM THE TIP OF THE SCOPE DURING THE PROCEDURE CAUSED CAUTERY OF THE DUODENAL WALL. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. TWO SEPARATE INCIDENTS WERE REPORTED INVOLVING SEPARATE ED-580XT SCOPES. THIS REPORT ADDRESSES THE SECOND SCOPE WITH SERIAL # (B)(4). THERE WAS NO DEATH ASSOCIATED WITH THE EVENT, AND THE BURN WAS DETERMINED TO BE MINOR. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Bowel Burn

  MAUDE report 14219713 ↗
• MalfunctionApr 27, 2022Improper or Incorrect Procedure or Method; Electrical Shorting; Improper or Incorrect Procedure or Method; Electrical Shorting

  ON (B)(6), 2022, FUJIFILM CORPORATION WAS INFORMED OF AN INCIDENT THAT OCCURRED DURING AN ERCP PROCEDURE INVOLVING ED-580XT. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPHINCTEROTOMY, THE SUBJECT SCOPE CUT RIGHT AND BURNED THE DUODENUM. THE PERFORMING PHYSICIAN STATED THAT LEAKAGE FROM THE TIP OF THE SCOPE DURING THE PROCEDURE CAUSED CAUTERY OF THE DUODENAL WALL. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. TWO SEPARATE INCIDENTS WERE REPORTED INVOLVING SEPARATE ED-580XT SCOPES. THIS REPORT ADDRESSES THE FIRST SCOPE WITH SERIAL # (B)(4). THERE WAS NO DEATH ASSOCIATED WITH THE EVENT, AND THE BURN WAS DETERMINED TO BE MINOR. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Bowel Burn

  MAUDE report 14219707 ↗
• InjuryApr 27, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON (B)(6) 2022, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLVING ED-580XT. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE DISTAL CAP CAME OFF OF THE SUBJECT SCOPE AND THE CAP REMAINED INSIDE THE PATIENT. THE ATTENDING TEAM NOTICED THAT THE CAP WAS MISSING AFTER THE SCOPE HAD BEEN REMOVED FROM THE PATIENT. ANOTHER ENDOSCOPIC PROCEDURE HAD TO BE PERFORMED IN ORDER TO RETRIEVE THE CAP. THE CAP WAS REMOVED WITHOUT HARM OR INJURY TO THE PATIENT. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14218691 ↗
• MalfunctionApr 27, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON APRIL 6, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING ED-580XT. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE DISTAL CAP CAME OFF OF THE SUBJECT SCOPE AND THE CAP REMAINED INSIDE THE PATIENT. THE ATTENDING TEAM NOTICED THAT THE CAP WAS MISSING AFTER THE SCOPE HAD BEEN REMOVED FROM THE PATIENT. ANOTHER ENDOSCOPIC PROCEDURE HAD TO BE PERFORMED IN ORDER TO RETRIEVE THE CAP. THE CAP WAS REMOVED WITHOUT HARM OR INJURY TO THE PATIENT. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14218683 ↗
• MalfunctionApr 21, 2022Improper or Incorrect Procedure or Method; Electrical Shorting; Improper or Incorrect Procedure or Method; Electrical Shorting

  ON MARCH 28, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN ADVERSE EVENT INVOLVING ED-580XT. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPHINCTEROTOMY, THE SUBJECT SCOPE CUT RIGHT AND BURNED THE DUODENUM. THE PERFORMING PHYSICIAN STATED THAT LEAKAGE FROM THE TIP OF THE SCOPE DURING THE PROCEDURE CAUSED CAUTERY OF THE DUODENAL WALL. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. TWO SEPARATE INCIDENTS WERE REPORTED INVOLVING SEPARATE ED-580XT SCOPES. THIS REPORT ADDRESSES THE SECOND SCOPE WITH SERIAL # (B)(4). THERE WAS NO DEATH ASSOCIATED WITH THE EVENT, AND THE BURN WAS DETERMINED TO BE MINOR. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Bowel Burn

  MAUDE report 14166907 ↗