NA 72201919FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556572818), received between Jan 10, 2018 and Dec 28, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 28, 2018Temperature Problem

  IT WAS REPORTED THAT THE DEVICE POWERED OFF A COUPLE OF TIMES DURING THE CASE AND THE BACK OF IT GOT REALLY HOT. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203085 ↗
• MalfunctionSep 17, 2018Material Discolored; Malposition of Device

  IT WAS REPORTED THAT THE COLOR WENT GREY THEN THE DEVICE BLACKED OUT. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881867 ↗
• MalfunctionJan 10, 2018Self-Activation or Keying

  IT WAS REPORTED THAT THE CAMERA TURNS ON AND OFF BY ITSELF. NO BACKUP WAS READILY AVAILABLE, DESPITE CONTACT WITH REPORTER IT IS UNKNOWN IF PROCEDURE WAS COMPLETED WITH THE SAME DEVICE OR WITH A COMPETITIVE ONE. NO PROCEDURE DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180666 ↗