MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOCAM; LOGIC 4K CAMERA HEAD C-MOUNT

Model Number	85525942
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The user reports that the surgery took longer than expected while patient was under sedation.In richard wolf gmbh risk analysis e2 rev.R01, manufacturing, handling, and design-related hazards regarding functional impairments, as well as risks arising from a non-functional product and resulting delays in surgery time, were considered in light of the corresponding severity of harm and the assumed probability of occurrence and assessed as an acceptable risk.In addition, chapter 8 of the instructions for use bb-a282-05 / en / us / v2.0 / 2021-07 / pk21-0089 instructs the user to perform a visual and functional inspection before and after each use.Among other things, a functional test must be performed using the corresponding camera controller, whereby a clear live image must be visible on the monitor after connecting the camera head.Potential functional impairments of the type described above can be easily detected if these instructions are followed.Furthermore, users are advised in chapters 2 and 4.3 that a functional, equivalent system should always be available due to potential failures.A search of the richard wolf mdr database over the past two years revealed no previous reports of a similar issue classified as a reportable event resulting in death or serious injury.Based on the information available and the fact that a 30-minute delay occurred, rw gmbh consider this case to be a reportable malfunction.

• Brand Name: ENDOCAM
• Common Device Name: LOGIC 4K CAMERA HEAD C-MOUNT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 24626844
• Report Number: 9611102-2026-00007
• Device Sequence Number: 8853160
• Product Code: FET
• UDI-Device Identifier: 04055207063163
• UDI-Public: 04055207063163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 85525942
• Device Catalogue Number: 85525942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown