PENTAX EG-1690KRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04961333225743), received between Nov 13, 2020 and Oct 1, 2025 — classified as 6 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2025Improper Flow or Infusion; Improper Flow or Infusion

  PENTAX MEDICAL RECEIVED A VOLUNTARY MEDWATCH REPORT (B)(4) FROM AN FDA MEDSUN PROGRAM USER FACILITY VIA EMAIL ON SEPTEMBER 12, 2025. ACCORDING TO THE USER REPORT, THE INSUFFLATION BECAME INADEQUATE DURING THE ENDOSCOPIC PROCEDURE. AS A RESULT, THE INSIDE OF THE BODY COULD NOT BE VISUALIZED, AND THE SPECIMEN COLLECTION PROCEDURE WAS DISCONTINUED. AFTER THE PROCEDURE, THE ENDOSCOPE CONCERNED WAS INSPECTED, AND THE INSUFFLATION FAILURE WAS REPRODUCED. THE DISTRIBUTOR WAS CONTACTED REGARDING THIS EVENT, AND THE ENDOSCOPE WAS SENT FOR INVESTIGATION. THERE WAS NO REPORT OF PATIENT HARM. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23188720 ↗
• MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BENDING RUBBER MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501520 ↗
• MalfunctionFeb 19, 2025Fluid/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 21407854 ↗
• MalfunctionFeb 13, 2025Optical Obstruction; Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371182 ↗
• InjuryOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DUE TO AN EMERGENCY, AN EXAMINATION WAS CONDUCTED WITH EG-1690K THAT HAD NOT BEEN USED FOR A LONG TIME AND HAD BEEN STORED IN A WAREHOUSE, AND THE BENDING RUBBER FELL OUT INSIDE THE PATIENT'S BODY. THE BENDING RUBBER THAT HAD FALLEN OFF INSIDE THE PATIENT'S BODY COULD NOT BE RETRIEVED. AFTER THE EXAMINATION, THE DOCTOR DETERMINED THAT THERE WAS NO HEALTH HAZARD TO THE PATIENT AND NO EXPLANATION WAS GIVEN TO THE PATIENT. THE HOSPITAL DIRECTOR ALSO SAID THAT THE EVENT WILL NOT BE REPORTED TO THE ADMINISTRATION. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. 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: Device Embedded In Tissue or Plaque

  MAUDE report 20553454 ↗
• InjuryOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20546262 ↗
• MalfunctionOct 10, 2024Erratic 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 20414427 ↗
• MalfunctionJun 23, 2023No Display/Image; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189161 ↗
• InjuryJun 6, 2023Suction Problem; Insufficient Flow or Under Infusion; Suction Problem; Insufficient Flow or Under Infusion

  PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, ENDOSCOPE USED DURING PROCEDURE FAILED TO BLOW AIR AND ALLOW INSUFFLATION OF THE UPPER GI TRACT PRECLUDING COMPLETION OF THE PROCEDURE SAFELY. THE PROCEDURE WAS THEREFORE SUSPENDED, AND FOLLOWED BY MULTIPLE TROUBLESHOOTING STEPS THAT FAILED UNTIL THE SCOPE WAS CHANGED (LARGER SCOPE AVAILABLE ON SITE). THEREFORE, TEAM HAD TO REQUEST EQUIVALENT 17 SERIES SCOPE, WHICH, AFTER INHERENT DELAY, WAS USED TO COMPLETE THE ENDOSCOPY UNEVENTFULLY. PATIENT HAD INCREASED DURATION OF PROCEDURE OVER ROUTINE 5 MINS. THERE ARE SEVERAL EVENTS, AND THIS ISSUE HAS BEEN EXPERIENCED BY SEVERAL PHYSICIANS. IN ALL INSTANCES, THE PROCEDURE (USUALLY BUT NOT EXCLUSIVELY A COLONOSCOPY) STARTS UNEVENTFULLY. DURING THE PROCEDURE, MORE LIKELY IF PROLONGED / POOR CLEANOUT, THE ENDOSCOPE SUCTIONS THE LUMINAL CONTENTS WITHOUT THE SUCTION BUTTON BEING PRESSED. ONCE THIS STARTS, IT TENDS TO GET WORSE. IN SOME CASES, CHANGING THE VALVE TO A NON-DISPOSABLE VALVE IMPROVED / RESOLVED THE ISSUE. THIS LEADS TO POOR AND NON-SUSTAINED INSUFFLATION OF THE INTESTINAL LUMEN, RESULTING IN POOR VISUALIZATION OF THE LUMEN. THIS IMPACTS: THE ABILITY TO IDENTIFY ABNOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076222 ↗
• InjuryJun 6, 2023Suction Problem; Insufficient Flow or Under Infusion; Suction Problem; Insufficient Flow or Under Infusion

  PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, ENDOSCOPE USED DURING PROCEDURE FAILED TO BLOW AIR AND ALLOW INSUFFLATION OF THE UPPER GI TRACT PRECLUDING COMPLETION OF THE PROCEDURE SAFELY. THE PROCEDURE WAS THEREFORE SUSPENDED, AND FOLLOWED BY MULTIPLE TROUBLESHOOTING STEPS THAT FAILED UNTIL THE SCOPE WAS CHANGED (LARGER SCOPE AVAILABLE ON SITE). THEREFORE, TEAM HAD TO REQUEST EQUIVALENT 17 SERIES SCOPE, WHICH, AFTER INHERENT DELAY, WAS USED TO COMPLETE THE ENDOSCOPY UNEVENTFULLY. PATIENT HAD INCREASED DURATION OF PROCEDURE OVER ROUTINE 5 MINS. THERE ARE SEVERAL EVENTS, AND THIS ISSUE HAS BEEN EXPERIENCED BY SEVERAL PHYSICIANS. IN ALL INSTANCES, THE PROCEDURE (USUALLY BUT NOT EXCLUSIVELY A COLONOSCOPY) STARTS UNEVENTFULLY. DURING THE PROCEDURE, MORE LIKELY IF PROLONGED / POOR CLEANOUT, THE ENDOSCOPE SUCTIONS THE LUMINAL CONTENTS WITHOUT THE SUCTION BUTTON BEING PRESSED. ONCE THIS STARTS, IT TENDS TO GET WORSE. IN SOME CASES, CHANGING THE VALVE TO A NON-DISPOSABLE VALVE IMPROVED / RESOLVED THE ISSUE. THIS LEADS TO POOR AND NON-SUSTAINED INSUFFLATION OF THE INTESTINAL LUMEN, RESULTING IN POOR VISUALIZATION OF THE LUMEN. THIS IMPACTS: THE ABILITY TO IDENTIFY ABNOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076221 ↗
• InjuryJun 5, 2023Suction Problem; Insufficient Flow or Under Infusion; Suction Problem; Insufficient Flow or Under Infusion

  REFER TO H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066893 ↗
• InjuryJun 5, 2023Suction Problem; Insufficient Flow or Under Infusion; Suction Problem; Insufficient Flow or Under Infusion

  PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, ENDOSCOPE USED DURING PROCEDURE FAILED TO BLOW AIR AND ALLOW INSUFFLATION OF THE UPPER GI TRACT PRECLUDING COMPLETION OF THE PROCEDURE SAFELY. THE PROCEDURE WAS THEREFORE SUSPENDED, AND FOLLOWED BY MULTIPLE TROUBLESHOOTING STEPS THAT FAILED UNTIL THE SCOPE WAS CHANGED (LARGER SCOPE AVAILABLE ON SITE). THEREFORE, TEAM HAD TO REQUEST EQUIVALENT 17 SERIES SCOPE, WHICH, AFTER INHERENT DELAY, WAS USED TO COMPLETE THE ENDOSCOPY UNEVENTFULLY. PATIENT HAD INCREASED DURATION OF PROCEDURE OVER ROUTINE 5 MINS. THERE ARE SEVERAL EVENTS, AND THIS ISSUE HAS BEEN EXPERIENCED BY SEVERAL PHYSICIANS. IN ALL INSTANCES, THE PROCEDURE (USUALLY BUT NOT EXCLUSIVELY A COLONOSCOPY) STARTS UNEVENTFULLY. DURING THE PROCEDURE, MORE LIKELY IF PROLONGED / POOR CLEANOUT, THE ENDOSCOPE SUCTIONS THE LUMINAL CONTENTS WITHOUT THE SUCTION BUTTON BEING PRESSED. ONCE THIS STARTS, IT TENDS TO GET WORSE. IN SOME CASES, CHANGING THE VALVE TO A NON-DISPOSABLE VALVE IMPROVED / RESOLVED THE ISSUE. THIS LEADS TO POOR AND NON-SUSTAINED INSUFFLATION OF THE INTESTINAL LUMEN, RESULTING IN POOR VISUALIZATION OF THE LUMEN. THIS IMPACTS: THE ABILITY TO IDENTIFY ABNOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061627 ↗
• MalfunctionMay 29, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016271 ↗
• MalfunctionMay 16, 2023Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ANGLE WIRE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936741 ↗
• MalfunctionApr 6, 2023No Display/Image; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688058 ↗
• MalfunctionApr 3, 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 16662038 ↗
• MalfunctionMar 16, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551313 ↗
• MalfunctionFeb 27, 2023Optical Obstruction; Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441636 ↗
• MalfunctionJan 31, 2023Component 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 16275465 ↗
• MalfunctionDec 7, 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 15929713 ↗
• MalfunctionDec 2, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ANGLE WIRE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903364 ↗
• MalfunctionNov 1, 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 15705632 ↗
• MalfunctionOct 14, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ANGLE WIRE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15602615 ↗
• 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 15388556 ↗
• 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 15308289 ↗

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