MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 32" 4K OLED SURGICAL DISPLAY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Model Number	0240031300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Alleged failure: oled monitor went black confirmed failure: aht-r-p2p loose components probable root cause: 1.Improper installation.2.Video cables are not sufficiently connected to ensure video transmission 3.Failure of edid negotiation 4.Failure of power supply 5.Failure or brownout of display voltage converter 6.User connects incompatible video source 7.Video source other than the one intended is selected for display 8.Damaged pins of hdmi / dvi connector 9.Open / short circuit failure between video connectors, tconn board and main board 10.Hard power switch on rear of display is in the off position 11.Failure / bug of scaler software 12.Incompatible cable used to connect video source to display 13.Cables have insufficient retention force 14.Cybersecurity event 15.Excessive usb current draw 16.Improper low voltage error setpoint the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence manufacture date is not known.

• Brand Name: PKG, 32" 4K OLED SURGICAL DISPLAY
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16753845
• Report Number: 0002936485-2023-00314
• Device Sequence Number: 8556650
• Product Code: FWB
• UDI-Device Identifier: 07613327592146
• UDI-Public: 07613327592146
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: 0240031300
• Device Catalogue Number: 0240031300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown