PENTAX EG-3890TKRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04961333227099), received between Sep 22, 2021 and Jun 18, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

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

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Obstruction of Flow

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542257 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480228 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307356 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853417 ↗
• MalfunctionJun 22, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17178771 ↗
• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000784 ↗
• MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984275 ↗
• MalfunctionNov 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15766595 ↗
• MalfunctionSep 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492452 ↗
• MalfunctionSep 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15388653 ↗
• MalfunctionAug 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15308285 ↗
• MalfunctionAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214979 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751492 ↗
• MalfunctionMay 30, 2022Component Missing; Component Missing

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539492 ↗
• MalfunctionMar 8, 2022Product Quality Problem; Separation Failure; Product Quality Problem; Separation Failure

  AIR/WATER NOZZLE MISSING. THERE WAS NO REPORT OF PATIENT HARM. THE TIME OF EVENT IS UNKNOWN. DATE OF EVENT: NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691945 ↗
• MalfunctionFeb 7, 2022Mechanical Problem; Mechanical Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE (B)(6). THE CUSTOMER REPORTED RIGHT/LEFT ANGULATION BROKEN INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG-3890TK, SERIAL NUMBER (B)(4). THE EVENT TIMING AND LOCATION ARE UNKNOWN. NO DEATH OR SERIOUS INJURY WAS REPORTED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476834 ↗
• MalfunctionJan 28, 2022Break; Break

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) INVOLVING PENTAX ENDOSCOPE MODEL EG-3890TK. IN THE EVENT REPORTED, THE USER STATED THE DEVICE IS BROKEN (NO ANGULATION). THE EVENT 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385619 ↗
• MalfunctionDec 7, 2021Partial Blockage; Device Fell; Partial Blockage; Device Fell

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO SCOPE EG-3890TLK. IN THE EVENT REPORTED, THE USER STATES THE PRIMARY CHANNEL IS BLOCKED. THE TIMING OF THE EVENT IS UNKNOWN. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951160 ↗
• MalfunctionSep 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES THAT FAILED THE WET AND DRY LEAK TESTING OUT OF THE BOX, INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG-3890TK, SERIAL NUMBER (B)(4). THE CUSTOMER IS SENDING THE DEVICE BACK TO PENTAX FOR EVALUATION. THE USER HAS TO CLEAN LOANERS OUT OF THE BOX BEFORE THEY CAN USE THEM ON A PATIENT. THE GASTROSCOPE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE EVENT OCCURRED AND THE FACILITY FOLLOWS INSTRUCTIONS FOR USE. THE LOANER ENDOCSCOPE WAS RETURNED WITH THE CUSTOMER OWNED ENDOSCOPE FOR EVALUATION ON 30-AUG-2021 UNDER SERVICE ORDER (B)(4). THE LOANER ENDOSCOPE IS CURRENTLY AWAITING INSPECTION AS OF 22-SEP-2021. MODEL EG-3890TK, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513193 ↗

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