Scintillant 2762-01-0003Recalls & reported problems
BihlerMed, L.L.C. · Scintillant Dual Bent Tip Surgical Light · Class 2
Data updated Oct 18, 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 10865082000143), received between Jun 13, 2023 and Jul 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE DISTRIBUTOR REGARDING A PATIENT UNDERGOING L2/3/4/5 OLIF AT LEVELS L2/3/4/5 FOR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE TIP OF THE BENT TIP FELL OUT WHEN ATTEMPTING TO REPLACE THE RADIANCE WITH THE RETRACTOR BLADE AFTER THE RETRACTOR WAS PLACED ON L4/5. THE PHYSICIAN NOTICED IT AND REMOVED IT. IT WAS USED WITHOUT A TIP. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17318248 ↗MalfunctionJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA THE DISTRIBUTOR REGARDING A PATIENT HAVING MICRODISCECTOMY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE TIP OF THE LIGHT SOURCE FELL OFF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119404 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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