ENDOCAM 5525301Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207063286), received between Jun 23, 2022 and Jul 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 7, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A LOGIC 4K CAMERA CONTROLLER, PART ID: 5525301, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, AT THE BEGINNING OF A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE VIDEO PROCESSOR WAS SWITCHED ON. THE OPTICS WERE ALREADY IN THE PATIENT'S URETHRA. AFTER COMPLETION OF THE VIDEO PROCESSOR'S SELF-TEST, A LARGE YELLOW BANNER WAS DISPLAYED ON THE MONITOR: "THE DEVICE MAY HAVE LIMITED FUNCTIONALITY. NOTIFY SERVICE! ERROR..." ALTHOUGH THE CAMERA DISPLAYED AN IMAGE ON THE MONITOR, IT WAS ALMOST COMPLETELY OBSCURED BY THE ERROR MESSAGE. CONFIRMATION / ACKNOWLEDGEMENT WAS NOT POSSIBLE, SO THE APPLICATION HAD TO BE INTERRUPTED AND A REPLACEMENT DEVICE HAD TO BE INTEGRATED.

  Patient problems: Insufficient Information

  MAUDE report 17280831 ↗
• MalfunctionJun 23, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED TO RWMIC (IMPORTER) THAT "THE SCREEN GOES IN AND OUT DURING CASE. NOT SURE IF IT'S THE CCU/MONITOR/STAND." THROUGH EMAIL, THE FOLLOWING INFORMATION WAS PROVIDED; ((B)(6) 2022): PAPERWORK FOR A LOANER DEVICE WAS SENT. ((B)(6) 2022): THE PROCEDURE WAS DELAYED 45 MINUTES. ANOTHER COMPANY'S VIDEO EQUIPMENT WAS BROUGHT IN DURING THE DELAY. THE PATIENT WAS GIVEN MORE ANESTHESIA DURING THE DELAY. THE PATIENT OUTCOME WAS STENT PLACEMENT. ((B)(6) 2022): CASE SCHEDULE AS AN URETEROSCOPY STENT PLACEMENT. THE PATIENT WAS GIVEN ADDITIONAL MEDICATION [ANESTHESIA] WHILE THE ISSUE WAS BEING RESOLVED, WHICH ALLOWS FOR A POTENTIAL RISK. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTED ISSUE OCCURRED? YES WAS. THERE INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO DID. THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? INITIALLY REPORTED AS NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. MDR AWARENESS DATE: 05/31/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787102 ↗
• MalfunctionJun 23, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED TO RWMIC THAT "THE SCREEN GOES IN AND OUT DURING CASE. NOT SURE IF IT'S THE CCU/MONITOR/STAND." THROUGH EMAIL, THE FOLLOWING INFORMATION WAS PROVIDED; (05/25/2022): PAPERWORK FOR A LOANER DEVICE WAS SENT. (05/27/2022): THE PROCEDURE WAS DELAYED 45 MINUTES. ANOTHER COMPANY'S VIDEO EQUIPMENT WAS BROUGHT IN DURING THE DELAY. THE PATIENT WAS GIVEN MORE ANESTHESIA DURING THE DELAY. THE PATIENT OUTCOME WAS A STENT PLACEMENT. (05/31/2022): THE PATIENT WAS GIVEN ADDITIONAL MEDICATION [ANESTHESIA] WHILE THE ISSUE WAS BEING RESOLVED, WHICH ALLOWS FOR A POTENTIAL RISK. CASE SCHEDULE AS AN URETEROSCOPY STENT PLACEMENT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTED ISSUE OCCURRED? YES. WAS THERE INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? INITIALLY REPORTED AS NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. RWMIC MDR AWARENESS DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787091 ↗