Pure-Vu PV-OS-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060513700052), received between Jun 26, 2018 and Jul 11, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequate or Insufficient Training” (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.

• InjuryJul 11, 2018Inadequate or Insufficient Training; Inadequate or Insufficient Training

  THE EVENT WAS REPORTED WITHIN A CLINICAL STUDY (IRB ID #: (B)(4)) AS AN ANTICIPATED EVENT. AFTER ANESTHESIA WORE OFF, PATIENT COMPLAINED OF ABDOMINAL PAIN. X-RAYS SHOWED FREE AIR; AN EXPLORATORY LAPAROSCOPY WAS PERFORMED ALONG WITH REPAIR OF PERFORATION. A 1 CM INJURY WAS FOUND AT THE RECTOSIGMOID JUNCTION OF THE COLON AND THIS WAS REPAIRED WITH SUTURING. THE PATIENT TOLERATED THE PROCEDURE WELL AND DISCHARGED 2 DAYS AFTER THE OPERATION WITH NO FURTHER COMPLICATIONS. THE EVENT MAY BE RELATED TO THE RETROFLEX ATTEMPTS THAT PHYSICIAN MADE DURING THE PROCEDURE. PERFORATIONS ARE AN ANTICIPATED RISK DURING COLONOSCOPY WHERE RETROFLEX IS KNOWN TO ELEVATE SUCH RISKS PARTICULARLY IN A NARROW ANATOMY; ISSUE WILL CONTINUE TO BE TRENDED.

  Patient problems: Bowel Perforation

  MAUDE report 7678091 ↗
• InjuryJun 26, 2018Inadequate or Insufficient Training; Inadequate or Insufficient Training

  DR. (B)(6) PERFORMED THE PROCEDURE AFTER REACHING CECUM, DURING WITHDRAW ABOUT 30CM INTO THE COLON, A SMALL PERFORATION WAS NOTICED. THE AREA OF PERFORATION HAD ABRASIONS AROUND IT. THEY SENT THE PATIENT TO X-RAY FOR CONFIRMATION OF PERFORATION. THE TEAR WAS CLOSED LAPAROSCOPICALLY WITH NO FURTHER COMPLICATIONS. THE PATIENT WAS RELEASED FROM THE HOSPITAL 12 HOURS AFTER THE COLONOSCOPY PROCEDURE. PERFORATIONS ARE AN ANTICIPATED RISK DURING COLONOSCOPY, NO NEW SAFETY ISSUE WAS RAISED FOLLOWING THIS EVENT.

  Patient problems: Bowel Perforation

  MAUDE report 7637447 ↗