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

Model Number	5525301
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf considers this mdr open.Rw will submit a follow-up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
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.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is the importer of this device.Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Follow-up report #1 is to provide fda with the device evaluation results and patient informations regarding this mdr.Device was evaluated by rwgmbh.According to investigation report device device evaluation, form 5020 (12): (9/01/2022) the device was tested visually.The reported condition was confirmed and the device did not meet specifications.The device was investigated in the responsible department.The device of complaint (b)(4) a was not returned from rwmic, so the devices could not be checked together.The camera socket was found deformed which could lead to a connection problem with the screen as it was reported.The user is advised in the related ifu ga-a282 /en-us/ 2020-05 v6.0/ pk20-0032 to check the device visually as well as functionally before and after each use in section 4 checks.Furthermore, the user is advised about the handling of the camera cable.The found device problem is caused by mechanical overload due lo improper plug-in and plugout of the camera.Probable root cause: user error; product disposition: (recomended) repair.The device for complaint (b)(4) a was sent to the responsible supplier (oem) for investigation.Rw considers this matter closed.However, if a new information becomes available, rw will submit a follow-up report.
Event or Problem Description
Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device investigation, as well as, new information collected for patient information.See manufacturers narrative, h10.

• Brand Name: ENDOCAM
• Common Device Name: LOGIC 4K CAMERA CONTROLLER
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; 75438 knittlingen, deu; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen, deu 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; 75438 knittlingen, deu; GM
• MDR Report Key: 14787102
• Report Number: 9611102-2022-00027
• Device Sequence Number: 12246227
• Product Code: FET
• UDI-Device Identifier: 04055207063286
• UDI-Public: 04055207063286
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5525301
• Device Catalogue Number: 5525301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FS-P3102D, S/N: (B)(6).
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Race: White