VIDEO GASTROSCOPE EG-2990IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333232512), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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.

• MalfunctionJun 23, 2021Device Reprocessing Problem; Physical Resistance/Sticking; Device Reprocessing Problem; Physical Resistance/Sticking

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2021 THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE ENDOSCOPE FAILED ADENOSINE TRIPHOSPHATE(ATP) TEST AFTER REPROCESSING INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG-2990I, SERIAL NUMBER (B)(4). ALTHOUGH THE USER FACILITY WAS ABLE TO CLEAN THE ENDOSCOPE, THERE WAS RESISTANCE EXPERIENCED AND THEY WERE NOT SURE IF SOMETHING WAS STUCK IN THE CHANNEL. NO PATIENT INVOLVEMENT WAS REPORTED. THE USER FACILITY RESPONDED TO GOOD FAITH EFFORT EMAILS ON 10-JUN-2021 DETAILING THE METHOD FOR REPROCESSING, CHEMICALS USED FOR REPROCESSING, AS WELL AS TESTING AND STORAGE DETAILS. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 03-JUN-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER 3133570 AND THE TECHNICIAN DID NOT IDENTIFY ANYTHING STUCK WITHIN THE ENDOSCOPE BUT DID NOTE "UMBILICAL CABLE SEVERE CRUSH" AND "SUCTION TUBE RESISTANCE" AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON (B)(6) 2021: PASSED DRY LEAK TEST, BENDING RUBBER GLUE CRACKING AT INSERTION TUBE SIDE, BENDING RUBBER GLUE CRACKING AT DISTAL SIDE, # 1 REMOTE CONTROL BU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051941 ↗

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