Integra® 0025001Recalls & reported problems
Integra Lifesciences Production Corporation · Lamp Only, 9300XSP · Class 2
- 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 10381780168089), received between May 3, 2024 and May 3, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Melted1
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.
MalfunctionMay 3, 2024Melted; Melted
IT WAS REPORTED THAT THE BRACKET IN THE LIGHT SOURCE (B)(6) THAT HOLDS THE LENS HAS MELTED. THIS ISSUE WAS DISCOVERED BEFORE A PROCEDURE. NO PATIENT INJURY OCCURRED AND NO SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244091 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.