VISERA VIDEO SYSTEM AUTOCLAVABLE CAMERA HEAD OTV-S7H-VARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170179822), received between Jan 16, 2021 and Mar 19, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Leak/Splash; Poor Quality Image; Leak/Splash; Poor Quality Image

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE CAMERA HEAD EXHIBITED FLOODING OF CABLE AND IMAGING SECTION. THE IMAGE HAD BECOME BLURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933830 ↗
• MalfunctionSep 13, 2021No Display/Image; No Display/Image

  IT WAS REPORTED BY THE CUSTOMER, THE AUTOCLAVABLE CAMERA HEAD PRESENTED A BLACK SCREEN. THE PICTURE WAS BLACK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A PROCEDURE. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459753 ↗
• MalfunctionFeb 5, 2021Crack; Electrical /Electronic Property Problem; Poor Quality Image; Crack; Electrical /Electronic Property Problem; Poor Quality Image

  IT IS REPORTED AN HD AUTOCLAVABLE CAMERA HEAD WAS FOUND TO HAVE A BLURRY IMAGE. THERE WAS NO PATIENT IMPACT RELATED TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11285107 ↗
• MalfunctionJan 16, 2021No Display/Image; No Display/Image

  IT IS REPORTED DURING A DIAGNOSTIC URETEROSCOPY USING A HD AUTOCLAVABLE CAMERA HEAD, THE CAMERA STOPPED WORKING AND DISPLAYED THE (B)(4) ERROR CODE (UNSUPPORTED SCOPE). THE DEVICE WAS REBOOTED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. UPON FURTHER INSPECTION AFTER THE PROCEDURE, THE EVENT OCCURRED AGAIN AND THE CUSTOMER MADE THE DECISION TO RETURN THE DEVICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11182610 ↗