NvisionVLE Marking Probe 17mm 95301-M-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859591006065), received between Apr 12, 2019 and Apr 12, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN SELECTED A 17 MM NVISIONVLE OPTICAL PROBE, WHICH CONTAINS A 17 MM BALLOON, FOR OCT IMAGING. OPTICAL PROBE BALLOON WAS INFLATED TO 5PSI TO EVALUATE EVIDENCE OF STRICTURES, WHICH WERE NOTED TO BE ABSENT. THE BALLOON WAS THEN INFLATED TO 15 PSI. DURING THE VLE PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD A PROXIMAL ESOPHAGEAL WALL TEAR. UPON THIS OBSERVATION, THE VLE PROCEDURE WAS ENDED AND THE OPTICAL PROBE BALLOON WAS DEFLATED. PATIENT WAS FURTHER INSPECTED AND THE OBSERVED TEAR IN THE ESOPHAGEAL WALL WAS DETERMINED TO BE MOST LIKELY A PERFORATION. PERFORATION CLOSURE WAS ACHIEVED WITH ENDOSCOPIC CLIPS. PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION ON THE DAY OF PROCEDURE ((B)(6) 2019). THE FOLLOWING DAY ((B)(6) 2019), PERFORMING PHYSICIAN REVIEWED THE ESOPHAGRAM, REPORTING THAT THE ESOPHAGRAM SHOWED THAT THE TEAR WAS CLOSED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8508898 ↗