LOTTA 28164LLARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551279663), received between Mar 18, 2025 and Feb 16, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Material Disintegration

  IT HAS BEEN REPORTED THAT METAL SHAVINGS MAY HAVE DETACHED FROM THE SCOPE. METAL FLAKES/ SHAVINGS WERE VISIBLE ON THE ENDOSCOPE'S SURGICAL IMAGE. THESE WERE FLOATING AROUND IN THE VENTRICULAR SPACE. IT WAS NOT CLEAR WHETHER THESE CAME FROM THE ENDOSCOPE ITSELF, THE INSTRUMENTS USED, OR ANOTHER SOURCE. CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 24345312 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC VENTRICULOSTOMY IN 2022, AN INCIDENT OCCURRED THAT LED TO BLEEDING WITH CONSEQUENCES FOR THE PATIENT. THE PATIENT BECAME A NURSING CASE. DETAILED INFORMATION PROVIDED BY THE REPORTER ABOUT THE PROCEDURE: THE PATIENT'S HEAD WAS ADEQUATELY FIXED IN THE MAYFIELD CLAMP. THE GUIDE SLEEVE WAS NAVIGATIONALLY INTRODUCED INTO THE LATERAL VENTRICLE AND THEN UNDER VISUALISATION AND NAVIGATIONAL GUIDANCE THROUGH THE FORAMEN MONROI INTO THE 3RD VENTRICLE. DURING THIS PROCESS, THE ASSISTANT HELD THE ENDOSCOPE AT THE LEVEL OF THE BURR HOLE WITH HIS FINGERS AND FIXED THE ENTRY POINT AT THE BURR HOLE. DUE TO CONTAMINATION, THE OPTIC WAS PULLED OUT AND CLEANED. WHEN REINSERTING THE OPTIC, THE SURGEON HELD THE ENDOSCOPE WITH THE AFFERENT IRRIGATION AND THE EFFERENT DRAINAGE WITH HIS LEFT HAND AND INSERTED THE OPTIC WITH HIS RIGHT HAND. A WOBBLING MOTION OCCURRED DUE TO A CATCH WHEN THE OPTICS WERE INSERTED INTO THE GUIDE SLEEVE. IT WAS LATER VISIBLE IN THE MRI THAT THE ENDOSCOPE SLIPPED FURTHER INWARDS AS A RESULT AND THERE WAS A CONTUSION OF THE MIDBRAIN.

  Patient problems: Insufficient Information

  MAUDE report 21637714 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC VENTRICULOSTOMY IN 2022, AN INCIDENT OCCURRED THAT LED TO BLEEDING WITH CONSEQUENCES FOR THE PATIENT. THE PATIENT BECAME A NURSING CASE. DETAILED INFORMATION PROVIDED BY THE REPORTER ABOUT THE PROCEDURE: THE PATIENT'S HEAD WAS ADEQUATELY FIXED IN THE MAYFIELD CLAMP. THE GUIDE SLEEVE WAS NAVIGATIONALLY INTRODUCED INTO THE LATERAL VENTRICLE AND THEN UNDER VISUALISATION AND NAVIGATIONAL GUIDANCE THROUGH THE FORAMEN MONROI INTO THE 3RD VENTRICLE. DURING THIS PROCESS, THE ASSISTANT HELD THE ENDOSCOPE AT THE LEVEL OF THE BURR HOLE WITH HIS FINGERS AND FIXED THE ENTRY POINT AT THE BURR HOLE. DUE TO CONTAMINATION, THE OPTIC WAS PULLED OUT AND CLEANED. WHEN REINSERTING THE OPTIC, THE SURGEON HELD THE ENDOSCOPE WITH THE AFFERENT IRRIGATION AND THE EFFERENT DRAINAGE WITH HIS LEFT HAND AND INSERTED THE OPTIC WITH HIS RIGHT HAND. A WOBBLING MOTION OCCURRED DUE TO A CATCH WHEN THE OPTICS WERE INSERTED INTO THE GUIDE SLEEVE. IT WAS LATER VISIBLE IN THE MRI THAT THE ENDOSCOPE SLIPPED FURTHER INWARDS AS A RESULT AND THERE WAS A CONTUSION OF THE MIDBRAIN.

  Patient problems: Insufficient Information

  MAUDE report 21637708 ↗