ENDOCAM 5525106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207013199), received between Sep 29, 2022 and Sep 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  (B)(4) REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO (B)(4) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 5525106, SN (B)(4). "THIS ITEM IS MALFUNCTIONING AND NEEDS TO BE CHECKED. IT OFTEN FAILS TO WHITE BALANCE WITH A PERFECTLY CLEAR SCOPE. THE CUSTOMER HAD TO CANCEL A CASE ON (B)(6) 2022 WITH THE PATIENT UNDER ANESTHESIA. THE PATIENT WAS NOT INJURED." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED SEPTEMBER 14, 2022) WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY 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? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. ADDITIONAL INFORMATIONS PROVIDED BY USER FACILITY REPRESENTATIVE: (EMAIL DATED, SEPTEMBER 27, 2022): PURPOSE OF PROCEDURE: TREATMENT. WHAT WAS THE PROCEDURE: LAMINOTOMY. DECISION TO REPORT FROM RWGMBH: DUE TO THE FACT, THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503863 ↗
• MalfunctionSep 29, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 5525106, SN (B)(4). "THIS ITEM IS MALFUNCTIONING AND NEEDS TO BE CHECKED. IT OFTEN FAILS TO WHITE BALANCE WITH A PERFECTLY CLEAR SCOPE. THE CUSTOMER HAD TO CANCEL A CASE ON 9-13-2022 WITH THE PATIENT UNDER ANESTHESIA. THE PATIENT WAS NOT INJURED." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED (B)(6) 2022. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY 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? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. ADDITIONAL INFORMATIONS PROVIDED BY USER FACILITY REPRESENTATIVE: (EMAIL DATED, (B)(6) 2022 - PURPOSE OF PROCEDURE: TREATMENT. - WHAT WAS THE PROCEDURE: LAMINOTOMY. DECISION TO REPORT FROM RWG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503756 ↗