NA TL410USRecalls & reported problems
Karl Storz GmbH & Co. KG · POWER LED SAPHIRA, OPAL1 PDD · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551441800), received between Nov 17, 2025 and Nov 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT THE LIGHT SOURCE KEPT LOSING ITS HIVE CONNECTION DURING A BLADDER CANCER SURGERY. THEY HAD A PROCEDURE WHERE THE LIGHT SOURCE WAS NOT SHOWING CONNECTION TO THE VIDEO SYSTEM AND CUSTOMER WAS UNABLE TO USE BLUE LIGHT FOR PROCEDURE. THEY DID NOT KNOW THIS WAS AN ISSUE UNTIL THEY WENT TO SWITCH CAMERA HEAD TO BLUE LIGHT. THIS IS A BIG ISSUE SINCE THERE IS NO WAY FOR CUSTOMER TO TROUBLESHOOT DURING A PROCEDURE NOR KNOW IF IT'S WORKING BEFORE PROCEDURE. THE LIGHT SOURCE SEEMS TO RANDOMLY LOSE ITS HIVE CONNECTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577689 ↗
Other Light source system, diagnostic endoscopic devices
- D-LIGHT C 20133620-134Karl Storz GmbH & Co. KG · Light Source System, Diagnostic Endoscopic2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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