Olympus A63840ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761027298), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Melted” (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 16, 2026.

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.

• InjuryMar 13, 2019Melted; Melted

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE THE TIP OF THE DEVICE MELTED OFF AND FELL INSIDE THE PATIENT. THE TIP THEN FUSED WITH THE PATIENT. THE STAFF BROUGHT IN A SURGEON TO SURGICALLY REMOVE THE MELTED PIECE FROM THE PATIENT. IT WAS ALSO REPORTED THAT THE DOCTOR HAD THE ELECTROSURGICAL GENERATOR TURNED TO 100 WATTS FOR AN HOUR. THE PATIENT OUTCOME IS UNKNOWN AND IT IS UNKNOWN WHETHER THE MELTED PIECE WAS RETRIEVED FROM THE PATIENT OR NOT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8417754 ↗