aScope™ Duodeno 482001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05707480145287), received between Nov 4, 2021 and Dec 2, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem

  ERCP WAS PERFORMED ON AN ELDERLY PATIENT WITH AN ACTIVE BLEEDING ULCER AND BILATERAL UNDER EXTREMITY EDEMA AND, WHICH IS A SYMPTOM FOR A WIDE RANGE OF MEDICAL CONDITIONS INCLUDING CHRONIC HEART FAILURE. DURING THE PROCEDURE THE PHYSICIAN HAD DIFFICULTY EXITING THE STENT THROUGH THE DISTAL END OF THE WORKING CHANNEL. THE PHYSICIAN TRIED THREE UNSUCCESSFUL CONSECUTIVELY TIMES TO DELIVER THE STENT AND DURING THIS THE WIRE WAS RELEASED FROM THE ELEVATOR WHICH CONTRIBUTED TO A PROLONGED PROCEDURE. DURING THIS PROLONGED PROCEDURE THE PATIENT HAD A CARDIAC FAILURE. THE MALFUNCTIONING SCOPE WAS REMOVED, AND A NEW SCOPE WAS USED TO INSTALL THE STENT AND STABILIZE THE PATIENT. AFTER THE PROCEDURE THE PATIENT WAS REFERRED TO THE ICU.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema; Ulcer

  MAUDE report 12918119 ↗
• InjuryDec 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ERCP WAS PERFORMED ON AN ELDERLY PATIENT WITH AN ACTIVE BLEEDING ULCER AND BILATERAL UNDER EXTREMITY EDEMA AND, WHICH IS A SYMPTOM FOR A WIDE RANGE OF MEDICAL CONDITIONS INCLUDING CHRONIC HEART FAILURE. DURING THE PROCEDURE THE PHYSICIAN HAD DIFFICULTY EXITING THE STENT THROUGH THE DISTAL END OF THE WORKING CHANNEL. THE PHYSICIAN TRIED THREE UNSUCCESSFUL CONSECUTIVELY TIMES TO DELIVER THE STENT AND DURING THIS THE WIRE WAS RELEASED FROM THE ELEVATOR WHICH CONTRIBUTED TO A PROLONGED PROCEDURE. DURING THIS PROLONGED PROCEDURE THE PATIENT HAD A CARDIAC FAILURE. THE MALFUNCTIONING SCOPE WAS REMOVED, AND A NEW SCOPE WAS USED TO INSTALL THE STENT AND STABILIZE THE PATIENT. AFTER THE PROCEDURE THE PATIENT WAS REFERRED TO THE ICU.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema; Ulcer

  MAUDE report 12916713 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, PHYSICIAN USED ASCOPE DUODENO IN A GI PROCEDURE. NO MEDICAL DEVICE FAILURE WAS NOTED FOR THE DUODENOSCOPE DURING THE PROCEDURE. ON (B)(6) 2021, THE PATIENT CAME BACK WITH ABDOMINAL PAIN AND DURING FOLLOW-UP PROCEDURE A SMALL PERFORATION WAS FOUND. NO INFORMATION AVAILABLE ON WHICH BODY STRUCTURE PART THE PERFORATION WAS. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 12887243 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PHYSICIAN USED SCOPE DUODENO IN A GI PROCEDURE. NO MEDICAL DEVICES FAILURE WAS NOTED FOR THE DUODENOSCOPE DURING THE PROCEDURE. ON (B)(6) 2021 THE PATIENT CAME BACK WITH ABDOMINAL PAIN AND DURING FOLLOW-UP PROCEDURE A SMALL PERFORATION WAS FOUND. NO INFORMATION AVAILABLE ON WHICH BODY STRUCTURE PART THE PERFORATION WAS. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 12880680 ↗
• MalfunctionNov 4, 2021Detachment of Device or Device Component

  DURING PROCEDURE WHEN TRYING TO GET THE WIRE THROUGH THE BALLOON CATHETER THE ENDOSCOPIST EXPERIENCED PROBLEMS, A DETACHMENT BETWEEN THE OUTER PART OF HANDLE AND INSERTION TUBE WAS DETECTED. THE MAIN TUBE WAS STILL CONNECTED. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED, AND THE MALFUNCTIONING SCOPE WAS SUCCESSFULLY REMOVED AND REPLACED WITH A NEW SCOPE. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752533 ↗
• MalfunctionNov 4, 2021Mechanical Problem; Mechanical Problem

  DURING PROCEDURE WHEN TRYING TO GET THE WIRE THROUGH THE BALLOON CATHETER THE ENDOSCOPIST EXPERIENCED PROBLEMS, A DETACHMENT BETWEEN THE OUTER PART OF HANDLE AND INSERTION TUBE WAS DETECTED. THE MAIN TUBE WAS STILL CONNECTED. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED, AND THE MALFUNCTIONING SCOPE WAS SUCCESSFULLY REMOVED AND REPLACED WITH A NEW SCOPE. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750718 ↗