VIDEO COLONOSCOPE EC-3890LIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333232345), received between Jul 28, 2021 and Feb 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K131855); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022No Display/Image; No Display/Image

  NO VIDEO IMAGE. THIS EVENT OCCURRED AT THE TIME OF UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502466 ↗
• MalfunctionDec 15, 2021No Display/Image; No Display/Image

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO SCOPE EC-3890LI. IN THE EVENT REPORTED, THE USER STATES THERE WAS NO VIDEO/ERROR MSG, SCOPE NOT CONN. THE CUSTOMER STATED THE USER EXPERIENCED ERROR MESSAGE #5 - NO VIDEO. THE CUSTOMER ALSO STATED THAT NO ACCESSORY WAS USED DURING THE PROCEDURE AND THERE WERE NO PATIENT/USER INJURIES, ADVERSE EVENTS, DELAY OR MEDICAL INTERVENTION REPORTED.. THE TIMING IS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT. THIS EVENT MEETS THE REQUIREMENT FOR FDA REPORTABILITY; THEREFORE, SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009030 ↗
• MalfunctionJul 28, 2021No Display/Image; No Display/Image

  PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, "NO VIDEO IMAGE/ERROR MESSAGE, SCOPE NOT CONNECTING" INVOLVING PENTAX MODEL EC-3890LI/SERIAL (B)(4). ADDITIONAL INFORMATION FROM THE USER STATED THE EVENT OCCURRED DURING PRE-INSPECTION CHECK. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED TO PENTAX ON 07/07/2021. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: IMAGE INTERMITTENT, PASSED DRY/WET LEAK TESTS, CCD CIRCUIT BOARD LOOSE CENTER CONNECTION, #3 REMOTE CONTROL BUTTON STICKING. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, REMOTE CONTROL BUTTON,PCB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY. THE DEVICE HAS BEEN ROUTINELY SERVICED BY PENTAX SINCE INSTALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240441 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131855. One submission often covers many models, so check the product and lot details in each record.

• Z-2448-2021 · Jul 14, 2021 · Open, Classified
  Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC
• Z-2449-2021 · Jul 14, 2021 · Open, Classified
  Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Chan
• Z-1267-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC34-i10L
• Z-1268-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC38-i10L
• Z-0636-2017 · Aug 15, 2016 · Terminated
  Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2068-2016 · Apr 6, 2016 · Terminated
  Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti