Scintillant 2762-01-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10865082000150), received between Aug 2, 2021 and Dec 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LENS TIP OF THE SURGICAL LIGHT WAS MISSING AFTER THE SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880800 ↗
• MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA THE DISTRIBUTOR REGARDING A PATIENT HAVING SPINAL THERAPY FOR AN INDICATION OF L4 COMPRESSION. IT WAS REPORTED THAT THE DEVICE WAS INSTALLED IN A RETRACTOR AND PREPARED FOR USE. HOWEVER, THE DEVICE WAS REMOVED PRIOR TO USE AND THE LENS AT THE TIP OF THE LIGHT CAME OFF. THE COMPLAINANT STATED THAT THE LENS COULD BE REATTACHED, BUT DID NOT USE THE DEVICE AFTER REATTACHING THE LENS IN CASE IT DISLOCATED AGAIN. 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 15594711 ↗
• MalfunctionJan 6, 2022Sparking; Sparking

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A LIGHT SOURCE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS EXTENSIVE SPINAL CANAL STENOSIS, DEGENERATIVE SCOLIOSIS. REVISION SURGERY PERFORMED DUE TO RELAPSE OF SYMPTOM AFTER INITIAL DECOMPRESSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, SPARKS CAME OUT TWICE FROM THE TIP OF THE LIGHT SOURCE IN THE SURGICAL FIELD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE SPARKS OCCURRED TWICE ON ONE SIDE. TIMING OF THE FIRST SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. TIMING OF THE SECOND SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. THE PHYSICIAN HAD CONFIRMED THAT THERE WAS NO INJURY SUCH AS BURNS OR DISCOLORATION IN THE PATIENT'S SURGICAL FIELD DUE TO SPARKS. THERE WAS ALSO NO HEALTH DAMAGE TO THE SURGEON. AS A SUPPLEMENT, AFTER THE SECOND SPARK, SURGEON REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177596 ↗
• MalfunctionAug 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LENS OF THE SURGICAL LIGHT BROKE OFF. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260056 ↗