VIDEO BRONCHOSCOPE EB-1170KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333232154), received between Apr 24, 2021 and Sep 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K131028); 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 16, 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.

• MalfunctionSep 14, 2021Failure to Disconnect; Failure to Disconnect

  PENTAX MEDICAL BECAME AWARE OF AN EVENT THAT OCCURRED IN THE UNITED STATES DURING CLEANING AFTER A PROCEDURE. THE REPORTED DESCRIPTION FROM THE PENTAX MEDICAL SALES REP WAS THAT A BRUSH WAS STUCK/BROKEN IN THE BIOPSY CHANNEL INVOLVING PENTAX MEDICAL VIDEO BRONCHOSCOPE MODEL EB-1170K, SERIAL NUMBER (B)(4). THE SALES REP PROVIDED A RESPONSE TO OUR GOOD FAITH EFFORT VIA EMAIL ON 27-AUG-2021 STATING THAT THE BRUSH THAT BECAME STUCK WAS A XOGRAPH SINGLE USE CHANNEL CLEANING BRUSH, CS4010A. THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 19-AUG-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL" CONFIRMING THE CUSTOMER COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS: BROKEN ACCESSORY BLOCKING BIOPSY T-PIECE, INSERTION TUBE MILD CRUSH AT STAGE 3, INSERTION TUBE BUCKLES AT END OF ROOT BRACE, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED, # 1 REMOTE CONTROL BUTTON COVER CRACKED, # 3 REMOTE CONTROL BUTTON COVER CRACKED, INSERTION TUBE MILD CRUSH AT STAGE 1, INSERTION TUBE MILD CRUSH AT STAGE 2. THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471809 ↗
• MalfunctionAug 9, 2021Partial Blockage; Failure to Disconnect; Device Damaged by Another Device; Partial Blockage; Failure to Disconnect; Device Damaged by Another Device

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES OF A "BRUSH STUCK/BROKEN IN CHANNEL DURING REPROCESSING" INVOLVING PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). THE PENTAX MEDICAL SALES REP RESPONDED TO THE GOOD FAITH EFFORT REQUEST VIA EMAIL ON 28-JUL-2021, STATING THAT THE CLEANING BRUSH WAS A PENTAX MEDICAL CLEANING BRUSH, UNKNOWN MODEL AND LOT NUMBER. THEY ALSO CONFIRMED THAT THE PRODUCT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT AND THE FACILITY FOLLOWS OPERATION METHODS INSTRUCTIONS FOR USE (IFU). THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 14-JUL-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL" CONFIRMING THE CUSTOMER COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS: PASSED DRY LEAK TEST, PASSED WET LEAK TEST, # 1 REMOTE CONTROL BUTTON COVER CRACKED, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293420 ↗
• MalfunctionApr 24, 2021Failure to Disconnect; Failure to Disconnect

  PENTAX WAS MADE AWARE OF A COMPLAINT ON 25-MAR-2021 OF A "BRUSH STUCK/BROKEN IN CHANNEL" INVOLVING THE PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO THE GOOD FAITH EFFORT REQUEST VIA EMAIL ON ON 30-MAR-2021, STATING THAT THE CLEANING BRUSH WAS AN OEM CLEANING BRUSH, MODEL CS4010A, UNKNOWN LOT NUMBER, SIZE 1.8MM-3.2MM CLEANING BRUSH. THE CUSTOMER OWNED BRONCHOSCOPE WAS RETURNED FOR EVALUATION ON 31-MAR-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL AND BROKEN ACCESSORY BLOCKING BIOPSY T-PIECE" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 01-APR-2021: UMBILICAL CABLE BUCKLE AT CONTROL BODY SIDE, UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, UP/ DOWN BRAKE LEVER CRACKED, UP/ DOWN CONTROL KNOB/ LEVER CRACKED, FAILED DRY LEAK TEST, FAILED WET LEAK TEST, # 4 REMOTE CONTROL BUTTON COVER CRACKED, BENDING RUBBER LEAK AT MIDDLE SECTION, LEAK AT # 1 REMOTE CONTROL BUTTON COVER, BENDING RUBBER CUT, INSERTION TUBE BUCKLES AT END OF ROOT BRACE, INSERTION TUBE BUCKLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131028. One submission often covers many models, so check the product and lot details in each record.

• Z-2875-2016 · May 31, 2016 · Terminated
  Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as bio
• Z-2065-2016 · Apr 6, 2016 · Terminated
  Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
• Z-2076-2016 · Apr 6, 2016 · Terminated
  Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org
• Z-2326-2017 · Jan 11, 2011 · Terminated
  Video Naso pharyngo Laryngoscopes
• Z-2325-2017 · Jan 11, 2011 · Terminated
  Video Cytoscopes
• Z-2324-2017 · Jan 11, 2011 · Terminated
  Video Bronchoscope