PENTAX ED-3490TK (UDI 04961333225903)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333225903), received between May 18, 2020 and Oct 9, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2020Microbial Contamination of Device; Microbial Contamination of Device

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE ENDOSCOPE WAS CULTURED AT THE FACILITY AND IT CAME BACK POSITIVE, INVOLVING THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4) . ENVIRONMENTAL CULTURE PRELIMINARY REPORTS FROM (B)(6) 2020 SAMPLING COLLECTION WERE PROVIDED TO THE USER FACILITY ON (B)(6) 2020 TESTING IDENTIFYING STENOTROPHOMONAS MALTOPHILIA, GRAM NEGATIVE RODS. NOTE: FURTHER STUDIES SILL IN PROGRESS. THE CUSTOMER OWNED DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 21-SEP-2020. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL A SERVICE REPAIR TECHNICIAN UNDER SERVICE ORDER (B)(4) AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 24-SEP-2020: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, PRIMARY OPERATION CHANNEL RESISTANCE, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, LIGHTGUIDE CONNECTOR ROOT BRACE CUT, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED WET LEAK TEST, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, INSERTION TUBE BUMP AT EN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10659519 ↗
• MalfunctionMay 18, 2020Microbial Contamination of Device; Microbial Contamination of Device

  PENTAX MEDICAL BECAME AWARE OF A REPORT ON 22APR2020, "CUSTOMER STATED THAT THEY RECEIVED POSITIVE CULTURES AFTER MULTIPLE CYCLES OF REPROCESSING", INVOLVING PENTAX MEDICAL VIDEO DUODENO SCOPE, MODEL ED-3490TK/SERIAL NUMBER (B)(4). THE CUSTOMER OWNED VIDEO DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 17-APR-2020. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 21-APR-2020 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. THE VIDEO DUODENOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RING(0.5X1.3), DISTAL CASE/CAP, O-RINGS AND SEALS, REMOTE CONTROL BUTTON. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 23-FEB-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 (B)(6) 2016. PENTAX MODEL ED-3490TK, SERIAL NUMBER (B)(4) HAS BE

  Patient problems: No Patient Involvement

  MAUDE report 10065454 ↗
• MalfunctionMay 18, 2020Microbial Contamination of Device; Microbial Contamination of Device

  PENTAX MEDICAL BECAME AWARE OF A REPORT ON 22APR2020, "CUSTOMER STATED THAT THEY RECEIVED POSITIVE CULTURES AFTER MULTIPLE CYCLES OF REPROCESSING", INVOLVING PENTAX MEDICAL VIDEO DUODENO SCOPE, MODEL ED-3490TK/SERIAL NUMBER (B)(4). THE CUSTOMER OWNED VIDEO DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON (B)(6) 2020. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 21-APR-2020 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: DISTAL CAP/ CASE SCRATCHED, UP/ DOWN BRAKE KNOB/ LEVER MARKINGS FADED, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, PASSED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED DRY LEAK TEST, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. THE VIDEO DUODENOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: REMOTE CONTROL BUTTON, O-RINGS AND SEALS. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 28-AUG-2015 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO

  Patient problems: No Patient Involvement

  MAUDE report 10065452 ↗