PENTAX Medical VNL8-J10 (UDI 04961333225354)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04961333225354), received between Jul 4, 2021 and Nov 27, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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 20793828 ↗
• MalfunctionOct 10, 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 20414392 ↗
• MalfunctionFeb 2, 2023Break; 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 16287955 ↗
• MalfunctionJan 13, 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 16156228 ↗
• MalfunctionSep 19, 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 15452443 ↗
• MalfunctionJun 8, 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 14629531 ↗
• MalfunctionJun 2, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. ANGLE WIRE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14571175 ↗
• MalfunctionMay 23, 2022Optical Distortion; Optical Distortion

  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 14467812 ↗
• MalfunctionAug 6, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THIS EVENT OCCURED BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. DELIVERY DATE: AUGUST 21, 2019. ON (B)(6) 2021, I HAD VISITED AFTER BEING INFORMED THAT THE LIGHT INTENSITY OF THE SCOPE WAS DARK. CONFIRMED IN THE PRESENCE OF DR. BUT THE DARKNESS WAS NOT REPRODUCED. TIGHTENING IS PERFORMED DUE TO LOOSENESS OF THE SCOPE SLEEVE. COMPARED TO THE SUBSTITUTE, BUT NO PARTICULAR DARKNESS IS FELT . IT IS SAID THAT IT BECAME BRIGHTER BY TIGHTENING THE SLEEVE. PROCESSOR CONFIRMATION (NO ERROR CODE) JUST IN CASE. HAVE A LOOK AT THE SITUATION AT THIS TIME. ON (B)(6) 2021, I WAS INFORMED BY THE FACILITY THAT THE AMOUNT OF LIGHT WAS DARK, SO I REPLACED IT WITH A SUBSTITUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285955 ↗
• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, "UP/DOWN ANGULATION STUCK" INVOLVING PENTAX MODEL VNL8-J10/SERIAL (B)(4). THE FACILITY CONTACT ALSO STATED THE EVENT OCCURRED DURING PRE-INSPECTION CHECK. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED TO PENTAX FOR EVALUATION. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: SEGMENT CRUSHED, BENDING RUBBER RUPTURED, BENDING RUBBER LEAK AT MIDDLE SECTION, FORWARD BODY TRIM COLLAR CRACKED, LIGHT CARRYING BUNDLE HAS LESS THAN 70% TRANSMISSION. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, INSERTION FLEX TUBE W/SEGMENT, BENDING RUBBER, DISTAL ATTACHING PIN, SEGMENT STEEL BRAID, FWD BODY TRIM RING, DISTAL BODY WITH LCB. THIS IS THE FIRST TIME THE DEVICE IS BEING RETURNED FROM THE FACILITY FOR SERVICE SINCE INSTALL DATE OF SEPTEMBER 2019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284915 ↗
• MalfunctionAug 5, 2021No Display/Image; No Display/Image

  WHEN I CHECKED THE ENDOSCOPIC IMAGE BEFORE USING THE TEST, THERE WAS NOISE (BLACKOUT) IN THE IMAGE. (ALWAYS OCCUR). IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR HEALTHCARE PROFESSIONALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278848 ↗
• MalfunctionJul 22, 2021No Display/Image; No Display/Image

  THE USER FACILITY REPORTED A COMPLAINT TO CUSTOMER SERVICE ON 25-JUN-2021 FOR A "NO VIDEO IMAGE" THAT OCCURRED IN THE UNITED STATES INVOLVING PENTAX MEDICAL VIDEO NASO PHARYNGO LARYNGOSCOPE, MODEL VNL8-J10, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO GOOD FAITH EFFORT(GFE) EMAILS FROM 28-JUN-2021 AND 30-JUN-2021 VIA EMAIL ON 06-JUL-2021 HOWEVER THE ATTACHMENT ONLY INCLUDES A LINE STATING THAT "THE SCOPE HAS BEEN CHECKED ON TWO DIFFERENT PROCESSORS AND ONLY BLACK SCREEN COMES UP, NO OTHER IMAGE". NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL ANSWERS TO OUR QUESTIONS WERE ANSWERED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 07-JUL-2021. THE COLONOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN IDENTIFIED "IMAGE BLACKOUT" AS WELL DOCUMENTING THE FOLLOWING INSPECTION FINDINGS ON 13-JUL-2021: LEAK AT # 3 REMOTE CONTROL BUTTON COVER, UP/ DOWN CONTROL KNOB/ LEVER PLASTIC COVER @ PIVOT SEPARATED, SOME FUNCTIONS CANNOT BE CHECKED UNIT COMPROMISED BY FLUID, TRIM CAP MISSING, INSERTION TUBE SEVERE CRUSH AT STAGE 1, INSERTION TUBE SEVERE CRUSH AT STAGE 3, LEAK AT # 2 REMOTE CONTROL BUTTON COVER, # 4

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214279 ↗
• MalfunctionJul 15, 2021Break; Scratched Material; Material Split, Cut or Torn; Break; Scratched Material; Material Split, Cut or Torn

  ELONGATION OF SCOPE TIP HIFUKU RUBBER. THERE WAS NO ABNORMALITY IN THE LEAK CHECK. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171244 ↗
• MalfunctionJul 4, 2021Optical Distortion; Optical Distortion

  "THE CLOUDINESS OF THE IMAGE CONTINUES TO BE UNCLEAR, AND THE TIP IS CLEANED, BUT IT DOES NOT IMPROVE. IF YOU USE IT FOR A LONG TIME, THE CLOUDINESS MAY BE REMOVED. LT FEELS LIKE THERE IS WATER INSIDE (NO HOLES)" THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114672 ↗