VIDEO GASTROSCOPE EG29-I10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333232536), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K131902); they may or may not involve this specific model.

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

• MalfunctionDec 13, 2022Device Contamination with Body Fluid; Device Contamination with Chemical or Other Material; Device Contamination with Body Fluid; Device Contamination with Chemical or Other Material

  WRITER TOOK A CLEAN GASTROSCOPE FROM THE CUPBOARD AND WHEN STERILE WATER WAS FLUSHED THROUGH A DARK COLORED FLUID CAME OUT. WRITER CALLED IN RAYMOND (ONE OF UNIT MANAGERS) AND SHOWED THE FLUID. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.

• Z-0318-2017 · Aug 15, 2016 · Terminated
  Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2071-2016 · Apr 6, 2016 · Terminated
  Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti