DISPOSABLE DISTAL ATTACHMENT D-201-11304 (UDI 04953170278273)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170278273), received between May 23, 2022 and Jan 2, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DISPOSABLE DISTAL ATTACHMENT CAME OFF THE GASTROSCOPE IN THE MIDDLE OF AN UNKNOWN STANDARD PROCEDURE. THE EAR NOSE THROAT (ENT) STAFF WERE REQUIRED TO ASSIST IN THE RETRIEVAL OF THE CAP TO PREVENT IT FROM PASSING INTO THE TRACHEA, AND IT WAS RETRIEVED SUCCESSFULLY. THERE WAS NO MIS-DIAGNOSIS AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424897 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "MANAGEMENT OF GASTROINTESTINAL SUBEPITHELIAL TUMORS WITH ENDOSCOPIC RESECTION."     THIS STUDY WAS CONDUCTED TO EXPLAIN THE MANAGEMENT OF GASTROINTESTINAL SUBEPITHELIAL TUMORS (GI SETS) AND RESECTING GI SETS WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER) TO EXPLORE THE EFFICACY OF THIS TECHNIQUE. A TOTAL OF 39 PATIENTS WERE INVOLVED IN THIS STUDY. OUT OF THEM 36 WERE RESECTED BY ESD AND 3 WERE RESECTED BY STER. THE SURGICAL METHODS ESD AND STER WERE CONDUCTED USING THE DEVICE ENDOSCOPE GIFQ260J, DISTAL HOOD D-201-11 304, ELECTROCOAGULATION UNIT ESG 100, DUAL KNIFE, DUAL KNIFE J, IT KNIFE NANO AND OTHER DEVICES. THE MEAN TUMOR SIZE WAS 16.8 ± 1.3 MM. THE OVERALL PROCEDURAL TIME WAS 37.9 ± 4.6 MINUTES. COMPLICATIONS LIKE PERFORATIONS WERE OBSERVED IN THREE PATIENTS. THE STUDY CONCLUDED THAT ESD AND STER CAN BE AN EFFECTIVE MODALITY FOR THE DIAGNOSIS AND MANAGEMENT OF GI SETS IN A SELECTED GROUP OF PATIENTS. THE AUTHORS REPORTED MILD PAIN AFTER ESD, UNSPECIFIED BLEEDING AND UNSPECIFIED INFECTION. THE REPORTABLE EVENTS IDENTIFIED BY THE AUTHOR ARE: PERFORATION -(N=3). SUBCUTANEOUS EMPHY

  Patient problems: Perforation; Unspecified Respiratory Problem

  MAUDE report 14471763 ↗