D-LIGHT C 20133620-134Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551004654), received between Jul 30, 2025 and Jul 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Optical Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Defective Component; Optical Problem; Defective Component; Optical Problem

  IT WAS REPORTED THAT DURING A TURBT PROCEDURE ON (B)(6) 2025, THE UROLOGIST WAS USING BLUE LIGHT TO TAKE TISSUE SAMPLES TO CONFIRM IF THE PATIENT REQUIRED A CYSTECTOMY OR NOT. THE UROLOGIST RESECTED USING WHITE LIGHT BUT WAS NOT ABLE TO USE THE BLUE LIGHT TECHNOLOGY TO CONFIRM HE HAD REMOVED ALL OF THE CIS (CARCINOMA IN SITU). HE DID TRY TO GET A BIOPSY WHERE HE THOUGHT HE SAW THE ILLUMINATION AS THE LIGHT WORKED THE FIRST TIME, HE ACTIVE THE BLUE LIGHT BUT DIDN'T FOR THE ADDITIONAL ATTEMPTS. AFTER HE BIOPSIED, HE WENT ON TO RESECT THE BLADDER.

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

  MAUDE report 22667667 ↗
• InjuryJul 30, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING A TURBT PROCEDURE ON (B)(6) 2025, THE UROLOGIST WAS USING BLUE LIGHT TO TAKE TISSUE SAMPLES TO CONFIRM IF THE PATIENT REQUIRED A CYSTECTOMY OR NOT. THE UROLOGIST RESECTED USING WHITE LIGHT BUT WAS NOT ABLE TO USE THE BLUE LIGHT TECHNOLOGY TO CONFIRM HE HAD REMOVED ALL OF THE CIS (CARCINOMA IN SITU). HE DID TRY TO GET A BIOPSY WHERE HE THOUGHT HE SAW THE ILLUMINATION AS THE LIGHT WORKED THE FIRST TIME, HE ACTIVE THE BLUE LIGHT BUT DIDN'T FOR THE ADDITIONAL ATTEMPTS. AFTER HE BIOPSIED, HE WENT ON TO RESECT THE BLADDER.

  Patient problems: Insufficient Information

  MAUDE report 22667666 ↗