VIDEO GASTROSCOPE EG27-V10CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333244676), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Disconnect” (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 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.

• MalfunctionNov 13, 2020Failure to Disconnect; Failure to Disconnect

  DURING EVALUATION BY THE PENTAX MEDICAL SERVICE REPAIR DEPARTMENT ON 06-FEB-2020, AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" WAS IDENTIFIED INVOLVING MODEL EG27-V10C, SERIAL NUMBER (B)(4), AND THE COMPLAINT HANDLING UNIT WAS NOTIFIED. ON 26-MAY-2020, COMMUNICATIONS BETWEEN PENTAX MEDICAL COMPLAINT HANDLING UNIT AND MARKETING PRODUCT MANAGER ALONG WITH THE ASSETS AND USED EQUIPMENT COORDINATOR ESTABLISHED THE ENDOSCOPE WAS DELIVERED TO (B)(6) ON (B)(6) 2019 AS A DEMO UNIT AND RETURNED ON 08-AUG-2019. MARKETING CONFIRMED THE DEVICE WAS NOT AVAILABLE FOR SALES IN THE UNITED STATES AND THAT THERE IS NO KNOWN PATIENT INVOLVEMENT INVOLVING THIS DEMO UNIT, AND NO PATIENT RISK. THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN DOCUMENTED AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" DOCUMENTED UNDER SERVICE ORDER (B)(4) ON 06-FEB-2020. OTHER INSPECTIONAL FINDINGS INCLUDED: PRIMARY OPERATION CHANNEL RESISTANCE, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE INVESTIGATION AND REPAIR IS IN-PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840098 ↗