ASSI ASSI.FOC158/75Recalls & reported problems
Accurate Surgical & Scientific Instruments Corporation · Fiber Optic Light Cable 3.5mm x 2300mm; 7.5 ft., w/o adapters · Class 2
Data updated Oct 13, 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 00841645131946), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excessive Heating” (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.
Reports received per month
Most reported problems
Device problems
- Excessive Heating1
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.
MalfunctionMar 8, 2024Excessive Heating; Excessive Heating
PER USER FACILITY REPORT, DURING AN ELECTIVE FACELIFT AND BILATERAL REMOVAL OF EXCESSIVE TISSUE FROM UNDERNEATH EYES, THE LIGHT CORD FOR THE FACELIFT RETRACTOR -WITHOUT THE HANDHELD RETRACTOR ATTACHED- FELL FROM THE MAYO STAND WHILE THE LIGHT WAS STILL ON 100%. THE CORD FELL ONTO THE DRAPES OVER THE PATIENT'S ABDOMEN RESULTING IN A 1 MM BURN HOLE IN THE DRAPE. THE PATIENT'S SKIN WAS NOT BURNED AND THERE WAS NO INJURY AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865128 ↗
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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