PENTAX EE-1580KRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04961333228324), received between Nov 25, 2020 and May 7, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Optical Obstruction” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K961564); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108325 ↗
• MalfunctionDec 4, 2025Optical Obstruction; Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712508 ↗
• MalfunctionMay 14, 2025Obstruction of Flow; Obstruction 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 22015967 ↗
• MalfunctionNov 15, 2022Optical 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 15795300 ↗
• MalfunctionJun 2, 2022Break; Break

  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 14571174 ↗
• MalfunctionDec 10, 2020Failure to Disconnect; Failure to Disconnect

  THE REPORTED COMPLAINT RECEIVED ON 10-NOV-2020 OF "BRUSH STUCK/BROKEN IN CHANNEL" INVOLVING THE PENTAX MEDICAL VIDEO ESOPHAGOSCOPE MODEL EE-1580K, SERIAL NUMBER (B)(4). THE USER REPORTED THE ISSUE OCCURRED DURING REPROCESSING. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 18-NOV-2020. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE SERVICE REPAIR TECHNICIAN WAS ABLE TO CONFIRM THE USERS EXPERIENCE WITH STUCK ACCESSORY IN THE BIOPSY INLET T-PIECE AND PRIMARY OPERATIONAL CHANNEL, THEY ALSO DOCUMENT THE FOLLOWING INSPECTION FINDINGS ON 19-NOV-2020: RIGHT/ LEFT BRAKE KNOB LOOSE, FAILED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, FAILED DRY LEAK TEST, LEAK AT CONTROL BODY, CONTROL BODY CRACKED FROM SIDE BODY COVER AT PROXIMAL END, FLUID INVASION IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, CONTROL BODY MILD CORROSION INSIDE, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, INSERTION TUBE SCRATCHES AT STAGE 1, AND DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART. THE DEVICE UNDERWENT REPAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988851 ↗
• MalfunctionNov 25, 2020Failure to Disconnect; Failure to Disconnect

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 26-OCT-2020 REGARDING "ACCESSORY STUCK IN SCOPE" DURING REPROCESSING, INVOLVING PENTAX MEDICAL VIDEO ESOPHAGEOSCOPE, MODEL EE-1580K, SERIAL NUMBER (B)(4). THE REPORTING END USER STATED THAT THEY EXPERIENCED THE FAILURE DURING REPROCESSING. NO PATIENT INVOLVEMENT WAS REPORTED. THE REPORTER RESPONDED VIA PHONE AND EMAIL TO GOOD FAITH EFFORT ATTEMPTS ON 19-NOV-2020 AND STATED THAT HE "SPOKE WITH THE REPROCESSING PERSONNEL AND THEY TOLD ME[THE REPORTER] IT WAS A CLEANING SCOPE BRUSH PRODUCT NUMBER CS6021T. WHEN I PACKED THE SCOPE TO SEND IT TO YOU GUYS I COULD SEE A PART OF THE BRUSH STICKING OUT OF THE DISTAL END.". THE CUSTOMER OWNED VIDEO ESOPHAGEOSCOPE WAS RETURNED FOR EVALUATION ON 03-NOV-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN DID NOT CONFIRM THE CUSTOMER'S COMPLAINT BUT DID NOTE THAT THE OPERATION CHANNEL WAS TWISTED IN THE BENDING SECTION AS WELL AS DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 05-NOV-2020: PASSED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, SEGMENT CRUSHED, PASSED DRY LEAK TEST, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901231 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961564. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-0819-2012 · Sep 30, 2011 · Terminated
  EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.