n.a. 20133720-1Recalls & reported problems
Karl Storz GmbH & Co. KG · Cold Light Fountain D-LIGHT P SCB · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551004685), received between Oct 3, 2019 and Mar 20, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fire” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fire1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2023Fire; Fire
CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE CAUGHT ON FIRE; NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16573167 ↗InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, DURING A LAP CHOLE PROCEDURE, WHILE THEY WERE USING FLUOROSCOPY, THE LAPAROSCOPE WAS PULLED BACK AND THE TIP OF THE SCOPE WAS RESTED INSIDE OF THE TROCAR CANNULA (THE SCOPE WAS CONNECTED TO AN ACTIVE LIGHT CABLE THAT WAS PLUGGED INTO THE D-LIGHT P HIGH POWER LIGHT SOURCE; THIS RESULTED IN THE PATIENT BEING BURNED AT THE UMBILICUS TROCAR ENTRANCE SITE. THE BURN WAS NOTICED AFTER THE PROCEDURE. WE HAVE BEEN UNABLE TO OBTAIN ANY FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT.
Patient problems: Burn(s)
MAUDE report 9153838 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.