NA 72201919SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010645517), received between Nov 20, 2017 and Mar 1, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION THE CAMERA CONTROL UNIT WAS NOISY AND GETTING HOT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461527 ↗
• MalfunctionApr 11, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, THE CAMERA CONTROL UNIT HAD STATIC ON SCREEN AND DISPLAYED DIFFERENT COLORS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646819 ↗
• MalfunctionMar 10, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DISPLAY OF THE HIGH DEF 560P SOMETIMES BLACKED OUT AND THE BUTTON HAD NO GOOD RESPONSE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456791 ↗
• MalfunctionNov 13, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CAMERA CONTROL UNIT WAS NOT CAPTURING IMAGES. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10835455 ↗
• MalfunctionAug 20, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SERVICE CCU HAD THE IMAGE BLACKOUT. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10432765 ↗
• MalfunctionSep 17, 2018Loss of Power

  IT WAS REPORTED THAT THE COLOR WENT GREY THEN THE DEVICE BLACKED OUT. THERE WAS A SURGICAL DELAYR 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 7881855 ↗
• MalfunctionAug 1, 2018No Display/Image

  IT WAS REPORTED THAT THE IMAGE WAS LOST DURING THE CASE. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739941 ↗
• MalfunctionNov 22, 2017Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054887 ↗
• MalfunctionNov 20, 2017No Display/Image

  IT WAS REPORTED NO IMAGE WHEN PLUGGED IN. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7045844 ↗