n.a. 495NACRecalls & reported problems
Karl Storz GmbH & Co. KG · Fiber Optic Light Cable, 230cm, Ø3.5mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551290705), received between Jun 2, 2022 and Sep 7, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Misassembly by Users” (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
Device problems
- Misassembly by Users2
- Use of Device Problem1
Patient problems
- Burn(s)2
- Superficial (First Degree) Burn2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE LIGHT WAS SWITCHED ON WITHOUT THE OTHER END OF THE CORD BEING PLUGGED INTO THE SCOPE. THIS RESULTED IN A SMALL HOLE IN THE DRAPE NEAR THE PATIENT'S LOWER EXTREMITIES. THE PATIENT WAS ASSESSED, AND NO HARM HAD REACHED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17703269 ↗InjuryJun 7, 2022Misassembly by Users; Misassembly by Users
AT THE BEGINNING OF A HYSTERECTOMY PROCEDURE THE SURGEON NOTICED THE LIGHT CABLE WAS NOT ATTACHED TO THE SCOPE. THE SCOPE WAS ATTACHED AND AFTER THE PROCEDURE IN RECOVERY A NOTICEABLE "BLISTER LOOKING "MARK WAS DISCOVERED ON PATIENT'S RIGHT THIGH. BURN WAS ASSESSED BY PLASTIC SURGEON TO BE A "SUPERFICIAL BURN" AND RECOMMENDED ANTIBIOTIC OINTMENT.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 14626157 ↗InjuryJun 2, 2022Misassembly by Users; Misassembly by Users
AT THE START OF A HYSTERECTOMY PROCEDURE WITH DILATION AND CURETTAGE, THE LIGHT CABLE WAS NOTICED NOT TO BE CONNECTED TO THE SCOPE BUT LAID ON THE DRAPE. A BURN HOLE WAS FOUND ON THE DRAPE WHICH HAD BURNED THROUGH TO THE PATIENT'S SKIN ON RIGHT INNER THIGH.
Patient problems: Burn(s); Superficial (First Degree) Burn
MAUDE report 14576496 ↗
Other Light source, fiberoptic, routine devices
- Integra® 00MLXIntegra Lifesciences (Ireland) Limited · Light source, fiberoptic, routine189 reports
- L9000 0220210000Stryker Corporation · Light source, fiberoptic, routine99 reports
- SafeLight 0233050100Stryker Corporation · Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Stryker Corporation · Light source, fiberoptic, routine59 reports
- SafeLight 0233050200Stryker Corporation · Light source, fiberoptic, routine1 recall3 reports
- IRIS 0220180518Stryker Corporation · Light source, fiberoptic, routine43 reports
- n.a. 495NDKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine23 reports
- PRECISION 0220220000Stryker Corporation · Light source, fiberoptic, routine22 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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