DISTAL ATTACHMENT MH-588 (UDI 04953170364518)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170364518), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 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 · 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.

• MalfunctionMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL RESPONSE TO PERORAL ENDOSCOPIC MYOTOMY IN PATIENTS WITH IDIOPATHIC ACHALASIA AT A MINIMUM FOLLOW-UP OF 2 YEARS". THE LITERATURE REPORTED THE RESULT OF 75 PATIENTS WITH ACHALASIA OF THE PERORAL ENDOSCOPIC MYOTOMY PROCEDURE USING OLYMPUS DISTAL ATTACHMENT MH-588 FROM 2010 TO 2012. IN THE SUBJECT CASE, 1 CASE OF DISLODGED OF THE SUBJECT DEVICE OCCURRED, WHICH WAS SUCCESSFULLY TREATED ENDOSCOPICALLY WITHOUT CLINICAL SEQUELAE. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396949 ↗