PENTAX EB-1570KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333228102), received between Dec 31, 2020 and Aug 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 16, 2021Device Reprocessing Problem; Material Split, Cut or Torn; Device Reprocessing Problem; Material Split, Cut or Torn

  THIS EVENT OCCURRED DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. POTENTIAL ENDOSCOPE CONTAMINATION. (B)(6) 2021 TODAY WE HAD ISSUE WITHOUT WATER WHICH CAUSED OUR SCOPES TO EITHER NO GET CLEANED AFTER PROCEDURE OR THEY WERE CLEANED WITH DIRTY WATER. 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 12322709 ↗
• MalfunctionJul 29, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-008-C WHICH INCLUDED INSPECTION OF THE SUCTION ARM ON AFFECTED MODELS PURSUANT TO PREDEFINED INSPECTION CRITERIA (QS-397). THE OBJECTIVE OF THE INSPECTION WAS TO LOCATE PART C255-AB171 (SUCTION ARM) AND VERIFY IT IS NOT LOOSE. IF PART C255-AB171 (SUCTION ARM) IS FOUND LOOSE, THE DEVICE WAS CONSIDERED TO FAIL THE INSPECTION CRITERIA. THE CUSTOMER OWNED ENDOSCOPE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 28-JUN-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 29-JUN-2021: SUCTION ARM LOOSE, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, FAILED DRY LEAK TEST, UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, FAILED WET LEAK TEST, OPERATION CHANNEL- PRIMARY MILD RESISTANCE. INSPECTION OF THE SUCTION ARM WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE ENDOSCOPE'S REPAIRS TO BE PERFORMED WHERE THE LOOSE SUCTION ARM WILL BE CORRECTED, AND THE UNIT RETURNED TO INVENTORY UPON COMPLETION. PARTS REPLACED: O-RINGS AND SEALS, DISTAL END ASSY WITH TUBE, DISTAL JOINT SCREW M1, LIGHT GUIDE CABLE, INSER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246211 ↗
• MalfunctionDec 31, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-008-C WHICH INCLUDED INSPECTION OF THE SUCTION ARM ON AFFECTED MODELS PURSUANT TO PREDEFINED INSPECTION CRITERIA ((B)(4)). THE OBJECTIVE OF THE INSPECTION WAS TO LOCATE PART C255-AB171 (SUCTION ARM) AND VERIFY IT IS NOT LOOSE. IF PART C255-AB171 (SUCTION ARM) IS FOUND LOOSE, THE DEVICE WAS CONSIDERED TO FAIL THE INSPECTION CRITERIA. THE CUSTOMER OWNED VIDEO BRONCHOSCOPE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 04-DEC-2020. (B)(6). THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 07-DEC-2020: SUCTION ARM LOOSE, UMBILICAL CABLE SEVERE CRUSH, FAILED DRY LEAK TEST, FAILED WET LEAK TEST, #3 REMOTE CONTROL BUTTON NOT WORKING, #2 REMOTE CONTROL BUTTON NOT WORKING, #1 REMOTE CONTROL BUTTON NOT WORKING, #4 REMOTE CONTROL BUTTON NOT WORKING, # 4 REMOTE CONTROL BUTTON COVER CRACKED, INSERTION TUBE MILD DENT AT STAGE 1, LEAK AT # 4 REMOTE CONTROL BUTTON COVER. INSPECTION OF THE SUCTION ARM WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE ENDOSCOPE'S REPAIRS TO BE PERFORMED WHERE THE LOOSE SUCTION ARM WILL BE COR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103353 ↗

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-2324-2017 · Jan 11, 2011 · Terminated
  Video Bronchoscope
• Z-2325-2017 · Jan 11, 2011 · Terminated
  Video Cytoscopes