LENS 4K 72205058SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556757017), received between Sep 22, 2020 and Jun 5, 2024 — 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE CAMERA HEAD WAS HOT FROM USE, AND NO DAMAGED WAS PRODUCED TO THE PATIENT. THERE WAS A BACK-UP DEVICE AVAILABLE. NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469658 ↗
• MalfunctionMar 26, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT SEE THROUGH THE CAMERA HEAD. 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 11573982 ↗
• MalfunctionDec 23, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT WHEN THE CAMERA HEAD WAS PLUGGED IN NOTHING CAME UP ON THE SCREEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11069946 ↗
• MalfunctionSep 24, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT, THE "CAMERA HEAD" HAD A BLUE SCREEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAS NO LIVE IMAGE WHICH MAKES IT A REPORTABLE EVENT. 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 10579497 ↗
• MalfunctionSep 22, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE "CAMERA HEAD" HAD A WHITE DOT ON THE LENS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THE CAMERA HEAD EVALUATION REVEALED THERE WAS NO LIVE VIDEO OUTPUT, ONLY A RED SCREEN WITH RED LINES; THEREFORE, MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10566113 ↗