NvisionVLE Marking Probe 20mm 95301-M-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859591006072), received between Feb 14, 2017 and Mar 20, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of 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

Recent adverse event reports

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

• InjuryMar 20, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN SELECTED A 20 MM NVISIONVLE® OPTICAL PROBE, WHICH CONTAINS A 20 MM BALLOON, FOR THE OCT IMAGING EVALUATION. THE OPTICAL PROBE WAS INSERTED THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE, INFLATED, AND THE IMAGING PROCEDURE WAS PERFORMED SUCCESSFULLY. AT THE END OF THE IMAGING PROCEDURE, THE TECHNICIAN DEFLATED THE 20 MM BALLOON AND BEGAN TO REMOVE THE OPTICAL PROBE. AT THIS POINT, IT WAS NOTED THAT THE OPTICAL PROBE HAD DIFFICULTY BEING REMOVED FROM THE ENDOSCOPE. THE OPTICAL PROBE WAS REMOVED FROM ENDOSCOPE, HOWEVER THEY NOTICED THAT THE BALLOON WAS DETACHED FROM THE OPTICAL PROBE AND LODGED IN THE ENDOSCOPE CHANNEL. THE ENDOSCOPE WITH LODGED BALLOON WAS REMOVED FROM PATIENT. IT WAS OBSERVED THAT THE OPTICAL PROBE WAS LODGED IN THE ENDOSCOPE AND THE PROXIMAL END OF THE BALLOON WAS STILL PARTIALLY INFLATED. IT IS PRESUMED THAT THE BALLOON WAS NOT FULLY DEFLATED BEFORE TRYING TO REMOVE THE OPTICAL PROBE. THE OPTICAL PROBE'S BALLOON WAS REMOVED FROM THE ENDOSCOPE CHANNEL AND THE ENDOSCOPE WAS REINSERTED. UPON FURTHER EXAMINATION OF PATIENT AFTER THE OCT IMAGING PROCEDURE, TWO BLEEDING MUCOSAL TEARS NEAR THE ESOPHAGOGASTRIC JUNCTION WERE NOTICED. THE BLEEDING WAS STOPPED W

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 7354822 ↗
• InjuryFeb 14, 2017Detachment Of Device Component; Detachment Of Device Component

  AN NVISIONVLE MARKING PROBE (20MM) WAS PLACED THROUGH THE ENDOSCOPE INTO THE STOMACH. DURING THE PROCEDURE THE BALLOON WAS NOT INFLATING AS QUICKLY AS EXPECTED, THEREFORE A DECISION WAS MADE TO USE A NEW MARKING PROBE. THE PROCEDURE WAS ABORTED, AND THE REMAINING AIR WAS SUCTIONED TO DEFLATE THE BALLOON, HOWEVER THE PHYSICIAN PREMATURELY PULLED THE MARKING PROBE BACK THROUGH THE ENDOSCOPE AND THE BALLOON DETACHED FROM THE MARKING PROBE AND LODGED IN THE ENDOSCOPE CHANNEL. THE PHYSICIAN DECIDED TO ADVANCE THE SCOPE INTO THE STOMACH AND PUSH THE BALLOON FROM THE ENDOSCOPE CHANNEL USING BIOPSY FORCEPS INTO THE STOMACH. A SNARE WAS USED TO OBTAIN THE BALLOON FROM THE STOMACH. THE PATIENT WAS UN-HARMED, AND CASE COMPLETED USING THE NEW MARKING PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6329110 ↗