DISPOSABLE DISTAL ATTACHMENT D-201-11802 (UDI 04953170048395)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170048395), received between Feb 24, 2023 and Jan 5, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• InjuryJan 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED IN A MEDWATCH REPORT, A SCOPE CAP BROKE OFF INSIDE OF A PATIENT¿S ORAL CAVITY AND PHARYNX AND NEEDED TO BE REMOVED WITH RAT TOOTH FORCEPS. AN ADDITIONAL TWO CAPS BROKE BUT CAME OUT WITH THE SCOPE. THE EVENT OCCURRED DURING AN GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) UNDER GENERAL ANESTHESIA. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. THE REPORT IS LINKED TO PATIENT IDENTIFIERS: C23574155 (FELL IN PATIENT), (B)(6) (BROKE IN SCOPE), AND (B)(6) (BROKE IN SCOPE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452856 ↗
• InjuryJan 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED IN A MEDWATCH REPORT 3900900000-2023-8012, A SCOPE CAP BROKE OFF INSIDE OF A PATIENT¿S ORAL CAVITY AND PHARYNX AND NEEDED TO BE REMOVED WITH RAT TOOTH FORCEPS. AN ADDITIONAL TWO CAPS BROKE BUT CAME OUT WITH THE SCOPE. THE EVENT OCCURRED DURING AN ENDOSCOPIC GASTRIC PERORAL MYOTOMY (G-POEM) UNDER GENERAL ANESTHESIA. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. THE REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6). (BROKE IN SCOPE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452392 ↗
• MalfunctionJan 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA A MEDWATCH REPORT, THAT THE DISPOSABLE DISTAL SCOPE CAP BROKE OFF INSIDE OF A PATIENT'S ORAL CAVITY AND THE PHARYNX NEEDED TO BE REMOVED WITH RAT TOOTH FORCEPS. TWO ADDITIONAL CAPS BROKE, BUT CAME OUT WITH THE SCOPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6) FELL IN PATIENT) AND (B)(6) (BROKE IN SCOPE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439872 ↗
• MalfunctionJan 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA A MEDWATCH REPORT, THAT THE DISPOSABLE DISTAL SCOPE CAP BROKE OFF INSIDE OF A PATIENT'S ORAL CAVITY AND THE PHARYNX NEEDED TO BE REMOVED WITH RAT TOOTH FORCEPS. TWO ADDITIONAL CAPS BROKE, BUT CAME OUT WITH THE SCOPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6) (FELL IN PATIENT) AND (B)(6) (BROKE IN SCOPE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438462 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT STRATEGY FOR GIANT 0-IS TUMORS EXHIBITING MUSCLE LAYER TRACTION IN OUR HOSPITAL". HUGE 0-IS (STEMLESS) TUMORS OF THE LARGE INTESTINE MAY EXHIBIT HIGH FIBROSIS AND MUSCLE TRACTION, AND ARE CONSIDERED TO BE HIGHLY DIFFICULT CASES OF ESD. IN THE PAST, MUSCLE LAYER TRACTION WAS ONE OF THE GUIDELINES FOR STOPPING ESD, BUT IT IS BECOMING A LESION THAT CAN BE OVERCOME BY THE PROGRESS OF ESD DEVICES INCLUDING TRACTION DEVICES AND VARIOUS TREATMENT METHODS SUCH AS THE TUNNEL METHOD AND POCKET-CREATION METHOD REPORTED BY YAMAMOTO, HAYASHI ET AL. IN OUR HOSPITAL, THE TUNNEL METHOD IS THE BASIC STRATEGY FOR HUGE 0-IS TYPE TUMORS, AND THE DOUBLE TUNNEL METHOD (DT METHOD) IS USED FOR CASES WITH SEVERE FIBROSIS AND MUSCLE LAYER TRACTION IN THE CENTER, AND THE OUTLINE OF THE METHOD IS EXPLAINED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE PERFORATION - 1 PATIENT. DELAYED PERFORATION - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 10 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6): GIF-Q260J FOR A PATIENT IN CASE#2 WITH INTRAOPERATIVE PERFORATION, 2. (B)(6): GIF-H290T FOR A PATIENT IN CASE#2 WITH INTRAOPERATI

  Patient problems: Perforation

  MAUDE report 16440322 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT STRATEGY FOR GIANT 0-IS TUMORS EXHIBITING MUSCLE LAYER TRACTION IN OUR HOSPITAL". HUGE 0-IS (STEMLESS) TUMORS OF THE LARGE INTESTINE MAY EXHIBIT HIGH FIBROSIS AND MUSCLE TRACTION, AND ARE CONSIDERED TO BE HIGHLY DIFFICULT CASES OF ESD. IN THE PAST, MUSCLE LAYER TRACTION WAS ONE OF THE GUIDELINES FOR STOPPING ESD, BUT IT IS BECOMING A LESION THAT CAN BE OVERCOME BY THE PROGRESS OF ESD DEVICES INCLUDING TRACTION DEVICES AND VARIOUS TREATMENT METHODS SUCH AS THE TUNNEL METHOD AND POCKET-CREATION METHOD REPORTED BY YAMAMOTO, HAYASHI ET AL. IN OUR HOSPITAL, THE TUNNEL METHOD IS THE BASIC STRATEGY FOR HUGE 0-IS TYPE TUMORS, AND THE DOUBLE TUNNEL METHOD (DT METHOD) IS USED FOR CASES WITH SEVERE FIBROSIS AND MUSCLE LAYER TRACTION IN THE CENTER, AND THE OUTLINE OF THE METHOD IS EXPLAINED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS, INTRAOPERATIVE PERFORATION - 1 PATIENT, DELAYED PERFORATION - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 10 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6): (B)(4) FOR A PATIENT IN CASE#2 WITH INTRAOPERATIVE PERFORATION, 2. (B)(6): (B)(4) FOR A PATIENT IN CASE#2 WITH INTRAOPERATIVE PER

  Patient problems: Perforation

  MAUDE report 16439952 ↗