PENTAX EB-1970KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333228133), received between Jun 18, 2021 and Jun 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 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 DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON (B)(6) 2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON (B)(6) 2021: SUCTION ARM LOOSE, INSERTION TUBE SEVERE CRUSH AT STAGE 2, DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART, LIGHT CARRYING BUNDLE HAS LESS THAN 70% TRANSMISSION, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, FAILED WET LEAK TEST, UP/ DOWN BRAKE LEVER NON-PENTAX MATERIAL, FAILED DRY LEAK TEST, PRIMARY OPERATION CHANNEL RESISTANCE, CUSTOMER COMPLAINT CONFIRMED, # 1 REMOTE CONTROL BUTTON COVER CRACKED, UMBILICAL CABLE SINGLE MILD DISCOLORATION, INSERTION TUBE MILD CRUSH AT STAGE 1, INSERTION TUBE MILD CRUSH AT STAGE 2, HOLE IN # 4 REMOTE CONTROL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028187 ↗

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-2325-2017 · Jan 11, 2011 · Terminated
  Video Cytoscopes
• Z-2324-2017 · Jan 11, 2011 · Terminated
  Video Bronchoscope
• Z-2326-2017 · Jan 11, 2011 · Terminated
  Video Naso pharyngo Laryngoscopes