VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE OLYMPUS PEF TYPE VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170340376), received between Jan 26, 2021 and Apr 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0344-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionApr 5, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER CALLED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) TO INQUIRE INFORMATION ON HOW THE VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE SHOULD BE REPROCESSED, AND WHICH CHEMICAL AGENTS ARE COMPATIBLE WITH THE PEF-V. IT WAS REPORTED THAT DURING THE CALL, THE CUSTOMER STATED THAT THE FACILITY HAD BEEN STORING THE REPROCESSED SCOPE IN A CONTAINER INSTEAD OF HANGING THEM IN A DRYING CABINET. THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) REPRESENTATIVE THEN ADVISED THE CUSTOMER TO FOLLOW THE IFU STEP ON REPROCESSING AND STORAGE WHICH RECOMMEND THE SCOPE SHOULD BE HUNG VERTICALLY DURING STORAGE TO AVOID WATER POOLING IN THE CHANNELS AND BACTERIA GROWTH. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION OF INCORRECT REPROCESSING OF THE SCOPE STATED BY THE CUSTOMER DURING THE PHONE CALL TO THE OLYMPUS TECHNICAL ASSISTANCE CENTER. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687010 ↗
• MalfunctionJan 26, 2021Material Separation; Material Separation

  AS REPORTED, THE DISTAL END COVER OF THE VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE WAS DAMAGED. ACCORDING TO THE INITIAL REPORTER, THE RUBBER AT THE DISTAL TIP WAS BEEN PULLED OFF. THIS EVENT OCCURRED DURING REPROCESSING AND THEREFORE HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11230519 ↗