MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOCAM; LOGIC 4K CAMERA CONTROLLER

Model Number	5525301
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Logic 4k camera controller, part id 5525301, serial #(b)(6) was manufactured on 04/feb/2022.The batch consisted of 20 pieces.No issue was identified during production and no further complaints were received from the reported batch.
Event or Problem Description
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.
Additional Manufacturer Narrative
New information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.The logic 4k camera controller, part id: (b)(4), serial # (b)(6) was investigated at rwgmbh.During the inspection of the camera controller, according to test instruction pa01-001-9111, the customer complaint could not be reproduced despite a test run of 3 weeks.After production, the logic 4k camera controllers are checked for their electrical parameters in accordance with our test instruction pa01-001-9111 and subjected to a functional test.These test steps ensure that no products are delivered that have not met their specifications.The service life of the controller at the customer's is approx.15 months.During this time, it functioned faultlessly and has not yet been repaired at richard wolf.After a period of use of approx.15 months, the cause is assessed as not traceable after several weeks of testing.The present logic 4k camera controller of the type 5525301 with the serial number (b)(6) originates from the production order (b)(4), which was booked to the new goods warehouse on 04/feb/2022 with an order size of (b)(4) pieces.A review of the relevant production records did not show any return deliveries or special releases within the production lot.No comparable case has been registered for this type in the period under consideration.Based on the available evaluation information, there is no direct risk to the patient, user or third parties.In general, the user is advised in the associated instructions for use ga-a282 / en / int / v2.0 / 2021-08 / pk20-0139 under chapter 9 that a visual and functional check must be carried out before and after each use.Possible functional impairments of the above type can be easily detected by hospital staff if these instructions are followed.Chapter 5 also points out that a second, equivalent camera should be available in case of a possible device failure during therapeutic use.In the risk assessment e2-1, rev.04, handling-related, design-related, and manufacturing-related risks with regard to impaired physical properties, such as image restriction, functional restriction as well as hazards due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.

• Brand Name: ENDOCAM
• Common Device Name: LOGIC 4K CAMERA CONTROLLER
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• 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: 17280831
• Report Number: 9611102-2023-00046
• Device Sequence Number: 5281203
• Product Code: FET
• UDI-Device Identifier: 04055207063286
• UDI-Public: 04055207063286
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200617
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5525301
• Device Catalogue Number: 5525301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown