NA 72200561FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010608710), received between Jul 4, 2017 and Jan 13, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT WORKING, IT WAS CONNECTED AND NOTHING HAPPENED. NO CASE WAS 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 11165023 ↗
• MalfunctionDec 29, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CAMERA HEAD WAS CONNECTED TO THE LIGHT SOURCE AND NEVER WOULD COME ON. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. 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 11091632 ↗
• MalfunctionOct 15, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT, BEFORE A PROCEDURE, THE CAMERA HEAD HAD NO PICTURE. NO PATIENT INVOLVEMENT REPORTED. 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 10687446 ↗
• MalfunctionNov 13, 2018No Display/Image

  IT WAS REPORTED THAT THE DEVICE HAS IMAGE INTERFERENCE WITH COMPLETELY LOSS OF IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE, THERE IS NOT CRITICAL DELAY OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8065082 ↗
• MalfunctionJul 4, 2017No Display/Image

  IT WAS REPORTED THE CAMERA HEAD NON-AC (B)(4) WENT BLACK DURING A PROCEDURE. A BACK UP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685382 ↗