ENDOCAM 85525942Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207063163), received between Mar 19, 2022 and Mar 18, 2026 — classified as 1 injury, 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. 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.

• MalfunctionMar 18, 2026No Visual Prompts/Feedback

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE, THE INSTRUMENT, ENDOCAM LOGIC 4K CAMERA HEAD, WAS NOT BEING DETECTED BY THE 4K MEDICAL/VIDEO MONITOR AND FAILED TO DISPLAY A LIVE IMAGE. A 30 MINUTE DELAY OCCURRED WHILE THE STAFF TRIED TO TROUBLESHOOT BUT NONE HAVE RESOLVED THE ISSUE. ANOTHER ENDOCAM CAMERA HEAD WAS ATTAINED AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626844 ↗
• InjuryDec 22, 2023No Display/Image; No Display/Image

  A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING A LOGIC 4K CAMERA HEAD, PART ID: 85525942, S/N # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, WHEN SETTING UP THE EQUIPMENT FOR THE ENDOSCOPIC SPINE SURGERY THE STAFF NOTICED THAT THE CAMERA HEAD WAS NOT VISIBLE AND REGISTERED BY THE VIDEO PROCESSOR. MTA AND SERVICE TECHNICIAN FROM RICHARD WOLF DID A SEARCH FOR THE ERROR BUT DID NOT MANAGE TO GET THE CAMERA HEAD TO WORK AT ALL. AS THE PATIENT WAS ALREADY READY FOR THE SURGERY, THE SURGEON TOOK THE DECISION TO SWITCH TO OPEN SURGERY INSTEAD OF PLANNED ENDOSCOPIC SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18386255 ↗
• MalfunctionJun 22, 2023Overheating of Device; Overheating of Device

  A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A LOGIC 4K CAMERA HEAD C-MOUNT, PART ID: 85525942, SERIAL #: (B)(6). ACCORDING TO THE RECEIVED INFORMATION, IT WAS COMPLAINED THAT THE CAMERA HEAD HEATED UP SO MUCH THAT THE USER COULD NO LONGER HOLD IT IN HIS HAND. ALSO, IT WAS REPORTED THAT THIS EXTENDED THE OPERATING ROOM TIME BY 2 HOURS.

  Patient problems: Burning Sensation; Insufficient Information

  MAUDE report 17185875 ↗
• MalfunctionAug 29, 2022Excessive Heating; Excessive Heating

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). RICHARD WOLF GMBH (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM: IT WAS COMPLAINED THAT THE CAMERA HEAD HEATED UP SO MUCH THAT THE USER COULD NO LONGER HOLD IT IN HIS HAND. AS A RESULT, THE USER HAD TO STOP THE PROCEDURE AND CONTINUE IT THE NEXT DAY. NO INJURIES TO THE PATIENT, USER OR THIRD PARTIES WERE INDICATED. RWGMBH AWARENESS DATE, 01-AUG-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314679 ↗
• MalfunctionMar 19, 2022Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED TO RICHARD WOLF (B)(4) THAT "THE USER HAS REPORTED THAT THE IMAGE FLICKERED AND FAILED COMPLETELY DURING THE PROCEDURE WITH THE USE OF THE ERBE DEVICE. THERE WAS A DELAY OF 30 MINUTES, THE PROCEDURE COULD BE COMPLETED WITH ANOTHER CAMERA CABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827566 ↗