NvisionVLE Low Profile Imaging Probe, 0mm Working Distance 95501-LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859591006188), received between Apr 13, 2018 and Apr 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K143678); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN SELECTED A NVISIONVLE® LOW-PROFILE OPTICAL PROBE FOR THE OCT IMAGING EVALUATION. THE OPTICAL PROBE WAS PLACED INSIDE THE COMMON BILE DUCT AND IMAGING WAS PERFORMED SUCCESSFULLY. IT WAS REPORTED THAT THE SOFT TIP OF THE OPTICAL PROBE HAD BECOME DETACHED INSIDE THE ENDOSCOPE DURING REMOVAL. THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND REMOVED THE OPTICAL PROBE SOFT TIP FROM THE SCOPE. NO MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430716 ↗
• MalfunctionApr 13, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN SELECTED A NVISIONVLE® LOW-PROFILE OPTICAL PROBE FOR THE OCT IMAGING EVALUATION. IT WAS REPORTED THAT THE SOFT TIP OF THE NVISIONVLE LOW-PROFILE OPTICAL PROBE HAD BECOME DETACHED DURING A PROCEDURE TO IMAGE THE COMMON BILE DUCT. THE TIP DETACHED AFTER REMOVAL OF THE DEVICE FROM THE DUCT POST IMAGING. IT WAS NOTED THAT THERE WAS SIGNIFICANT OVER MANIPULATION REQUIRED TO PLACE THE LOW-PROFILE OPTICAL PROBE INTO THE DESIRED LOCATION DUE TO THE CHALLENGING AND DILATED ANATOMY. THE DETACHED TIP WAS RETRIEVED USING A RAT-TOOTHED FORCEPS. THE PATIENT WAS NOT HARMED IN THIS INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430612 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143678. One submission often covers many models, so check the product and lot details in each record.

• Z-1781-2018 · Apr 11, 2018 · Terminated
  NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251),