VIDEO DUODENOSCOPE ED-3490TKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333232420), received between Oct 4, 2020 and Oct 4, 2020 — classified as 1 malfunction.

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

• MalfunctionOct 4, 2020Device Reprocessing Problem; Residue After Decontamination; Device Reprocessing Problem; Residue After Decontamination

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 04-SEP-2020 THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION AS THE ENDOSCOPE FAILED ADENOSINE TRIPHOSPHATE(ATP) TEST 3 TIMES AFTER REPROCESSING, INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER H110912. NO PATIENT INVOLVEMENT WAS REPORTED. THE VIDEO DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 14-SEP-2020. THE VIDEO DUODENOSCOPE IS CURRENTLY AWAITING REPAIR, AND ORGANIC SAMPLING AS OF (B)(6) 2020. ON 22-SEP-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL ED- 3490TK, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-20-090019, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 28-JAN-2016 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 28-JAN-2016. PENTAX MEDICAL, MODEL ED-3490TK, SERIAL NUMBER (B) (4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2016. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10624536 ↗