PENTAX EB-1975KRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04961333226863), received between Feb 26, 2020 and Jan 17, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Optical 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 21175916 ↗
• MalfunctionOct 28, 2024No 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 20542145 ↗
• MalfunctionOct 15, 2024Fluid/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 20448308 ↗
• MalfunctionMay 15, 2023Break; Break

  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 16928497 ↗
• MalfunctionOct 5, 2022Break; Break

  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 15541744 ↗
• MalfunctionSep 9, 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 15388242 ↗
• MalfunctionSep 5, 2022Fluid/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 15354207 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PENTAX MEDICAL BECAME AWARE OF A REPORT ON (B)(6) 2020 STATING, "POSSIBLE CONTAMINATION-PATIENT TESTED POSITIVE FOR VIRUS. HARBORING INFECTION." INVOLVING VIDEO BRONCHOSCOPE MODEL EB-1975K/SERIAL (B)(4). THE CUSTOMER OWNED BRONCHOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON (B)(6) 2020. THE BRONCHOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON (B)(6) 2020 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: INSERTION TUBE MILD CRUSH AT STAGE 2, INSERTION TUBE MILD CRUSH AT STAGE 1, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE BRONCHOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: DISTAL END ASSY WITH TUBE, DISTAL JOINT SCREW M1, BENDING RUBBER, BIOPSY INLET T-PIECE, O-RINGS AND SEALS, INSERTION/S-NIPPLE ATTACHING SCREW, O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5). THE VIDEO BRONCHOSCOPE IS CURRENTLY AWAITING ORGANIC SAMPLING AND QC FINAL APPROVAL AS OF (B)(6) 2020. PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1975K, SERIAL NUMBER (B)(4), HAS BEEN PREVIOUSLY SERVICED AT A PENTAX FACILITY ONCE PRIOR SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2017.

  Patient problems: Viral Infection

  MAUDE report 9753436 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PENTAX MEDICAL BECAME AWARE OF A REPORT ON (B)(6) 2020 STATING, "POSSIBLE CONTAMINATION-PATIENT TESTED POSITIVE FOR VIRUS. HARBORING INFECTION." INVOLVING VIDEO BRONCHOSCOPE MODEL EB-1975K/SERIAL (B)(4). THE CUSTOMER OWNED BRONCHOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 05-FEB-2020. THE BRONCHOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 14-FEB-2020 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: INSERTION TUBE MILD CRUSH AT STAGE 2, INSERTION TUBE MILD CRUSH AT STAGE 1, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE BRONCHOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: DISTAL END ASSY WITH TUBE, DISTAL JOINT SCREW M1, BENDING RUBBER, BIOPSY INLET T-PIECE, O-RINGS AND SEALS, INSERTION/S-NIPPLE ATTACHING SCREW, O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5). THE VIDEO BRONCHOSCOPE IS CURRENTLY AWAITING ORGANIC SAMPLING AND QC FINAL APPROVAL AS OF 25-FEB-2020. PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1975K, SERIAL NUMBER (B)(4), HAS BEEN PREVIOUSLY SERVICED AT A PENTAX FACILITY ONCE PRIOR SINCE THE DEVICE WAS PUT INTO SERVICE ON 23-MAR-2017.

  Patient problems: Viral Infection

  MAUDE report 9753427 ↗

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