Integra® 001320LXRecalls & reported problems
Integra Lifesciences (Ireland) Limited · Integra® MLX Lamp Module · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780167969), received between Jun 10, 2019 and Mar 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Melted” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Melted1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024Melted; Melted
MalfunctionJun 10, 2019Overheating of Device; Overheating of Device
A SENIOR SERVICE ENGINEER REPORTED THAT THE 00MLX MLX 300W XENON LIGHTSOURCE OVERHEATED DURING INSTALLATION AT A HOSPITAL. THE MLX MACHINE WAS SWITCHED ON AND THE INTENSITY INCREASED TO 20 % TO 95%. THE FIBER OPTIC CABLE CONNECTOR GLASS WAS DAMAGED DUE TO THE OVERHEAT. THE MLX LIGHTSOURCE WAS CHECKED WITH ANOTHER FIBER OPTIC CABLE, WHICH WAS ALSO DAMAGED, HENCE TWO (2) FIBER OPTIC CABLES WERE DEFECTIVE. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT, INJURY, OR A SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8684384 ↗
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- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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