HD-VIEW 11272VHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551423226), received between Aug 14, 2024 and Aug 25, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439104 ↗
• MalfunctionAug 21, 2026Optical Distortion

  Patient problems: Insufficient Information

  MAUDE report 50376182 ↗
• MalfunctionJul 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT BLURRY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699823 ↗
• MalfunctionJun 2, 2026Poor Quality Image

  IT WAS REPORTED THAT THE DEVICE HAD AN IMAGE DISTORTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366156 ↗
• MalfunctionMar 3, 2026Leak/Splash; Optical Distortion

  THE FOLLOWING WAS REPORTED: ADHESIVE JOINTS ON THE LENSES HAVE SPLINTERED. IMAGE IS CLOUDY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24503010 ↗
• MalfunctionDec 2, 2025Circuit Failure; Erratic or Intermittent Display; Circuit Failure; Erratic or Intermittent Display

  THE FOLLOWING WAS REPORTED "LEAKAGE, IMAGE INTERFERENCE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697987 ↗
• MalfunctionMay 9, 2025Degraded; No Display/Image; Defective Component; Degraded; No Display/Image; Defective Component

  THE FOLLOWING WAS REPORTED "INSERTION SHAFT, ELECTRONICS CASING BRITTLE, NO IMAGE ". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998244 ↗
• MalfunctionFeb 26, 2025No Display/Image; Optical Problem; Material Split, Cut or Torn; No Display/Image; Optical Problem; Material Split, Cut or Torn

  FURTHER INFORMATION WAS RECEIVED ON 13-MAR-2025. REGARDING THE REPORTED ERROR IT WAS STATED ELECTRONIC NO IMAGE - LOOSE CONTACT. THE CYSTOSCOPE HAS A DEFECT (POSSIBLE TEAR) ON THE SHAFT (WHERE THE FLEXIBLE PART BEGINS). IT WAS ALSO CONFIRMED THAT THE DEFECT WAS ALREADY DETECTED IN THE MORNING DURING PREPARATIONS AND NOT DURING USE ON A PATIENT. FURTHER IT WAS STATED THAT THE PLANNED EXAMINATION (CYSTOSCOPY) HAD TO BE POSTPONED FROM THE ORIGINAL PLANNED DATE (B)(6) 2025) FOR 13 DAYS (A REPLACEMENT DEVICE WAS ALREADY RECEIVED ON (B)(6) 2025 BUT THERE WAS NO EARLIER TIME SLOT AVAILABLE FOR THE EXAMINATION). THE PATIENT DID NOT HAVE TO BE HOSPITALIZED DURING THIS TIME AND CAME BACK TO THE DOCTOR'S OFFICE ON THE RESCHEDULED APPOINTMENT. IT WAS CONFIRMED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE RESCHEDULED DATE AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

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

  MAUDE report 21470483 ↗
• InjurySep 23, 2024Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT THE EXAMINATION FAILED COMPLETION OF THE MEDICAL PROCEDURE DUE TO FAULTY NON CLEAR VISION FROM THE CAMERA LENS WAS REPORTED. NO HARM TO PATIENT, USER OR THIRD REPORTED. THERE IS NO INFORMATION WHETHER THE SURGERY NEEDED TO BE POSTPONED OR CHANGED, A DIFFERENT DEVICE WAS USED, AND WHICH MEDICAL INTERVENTION WAS NECESSARY. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 20285429 ↗
• InjuryAug 14, 2024Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT THE EXAMINATION FAILED COMPLETION OF THE MEDICAL PROCEDURE DUE TO FAULTY NON CLEAR VISION FROM THE CAMERA LENS WAS REPORTED. NO HARM TO PATIENT, USER OR THIRD REPORTED. THERE IS NO INFORMATION WHETHER THE SURGERY NEEDED TO BE POSTPONED OR CHANGED, A DIFFERENT DEVICE WAS USED, AND WHICH MEDICAL INTERVENTION WAS NECESSARY. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 19984463 ↗