DISPOSABLE DISTAL ATTACHMENT D-201-13404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170453885), received between Jul 13, 2023 and Jul 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT SIX (6) DISPOSABLE DISTAL ATTACHMENTS WERE BEING REPROCESSED AND USED. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 6 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507443 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "OUTCOMES OF ENDOSCOPIC FULL-THICKNESS RESECTION FOR GASTRIC SUBMUCOSAL TUMORS, A PROSPECTIVE STUDY". IN A HISTOLOGICALLY PROVEN SMALL GASTROINTESTINAL STROMAL TUMOR (GIST), STANDARD TREATMENT IS EXCISION, UNLESS MAJOR MORBIDITY IS EXPECTED. CURRENTLY, THE STANDARD METHOD TO EXCISE THE GASTRIC GIST IS SURGERY. HOWEVER, OUTCOMES OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR TREATMENT OF GASTRIC GIST ARE REPORTED MAINLY FROM CHINA. IN SEPTEMBER 2020, EFTR WAS APPROVED AS AN ADVANCED MEDICAL CARE FOR GASTRIC SMTS IN JAPAN. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED PERFORATION (N=1). ADDITIONAL INFORMATION FROM THE AUTHOR STATED THAT IN THE END, THE PERFORATION WAS SUTURED WITH AN INDWELLING SNARE AND A CLIP SO THERE WAS A POSSIBILITY THAT IT WAS LOOSE, BUT THE CAUSE IS UNKNOWN. ADDITIONALLY, THE AUTHOR CONFIRMED NO OLYMPUS EQUIPMENT MALFUNCTIONED DURING THE CASE. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) - D-201-13404 ; (B)(6) - GIF-2TQ260M. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Perforation

  MAUDE report 17317083 ↗