Distal Attachment MH-463Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170047756), received between May 2, 2023 and May 2, 2023 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jul 27, 2023Open, Classified

   The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

   Z-2523-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "EFFICACY OF SINGLE-BALLOON OVERTUBE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE PROXIMAL COLON: A PROPENSITY SCORE-MATCHED ANALYSIS". OBJECTIVES: A SINGLE-BALLOON OVERTUBE (SBO) CAN IMPROVE POOR SCOPE OPERABILITY DURING COLONIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD).WE AIMED TO EVALUATE THE CLINICAL USEFULNESS OF SBO FOR ESD IN THE PROXIMAL COLON AND THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. METHODS: A TOTAL OF 88 TUMORS LOCATED IN THE PROXIMAL COLON RESECTED BY BALLOON-ASSISTED ESD (BA-ESD) USING SBO AND 461 TUMORS RESECTED BY CONVENTIONAL ESD (C-ESD) BETWEEN JUNE 2015 AND NOVEMBER 2020 WERE CONSIDERED. SEVENTY-EIGHT TUMORS EACH IN THE BA-ESD AND C-ESD GROUPS WERE MATCHED BY PROPENSITY SCORE MATCHING. ESD OUTCOMES WERE COMPARED BETWEEN THE GROUPS, AND A DECISION TREE ANALYSIS WAS PERFORMED TO EXPLORE THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE MAJOR OUTCOMES SUCH AS EN BLOC RESECTION RATE (95% VS. 99%, P = 0.17), R0 RESECTION RATE (92% VS. 96%, P = 0.30), MEAN DISSECTION SPEED (16 MM2/MIN VS. 16 MM2/MIN,P = 0.53), AND INTRAOPERATIV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16855902 ↗