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

Catalog Number	0240031300
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
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
The device is the primary monitor.The oled screen turned white and would not route to a different screen.There was an image loss and it remained lost.The image never returned and the current monitor is no longer usable.To complete the procedure, there was another oled hanging in the room, and the procedure was finished with that monitor.This caused a delay of about 10 minutes.
Event or Problem Description
The device is the primary monitor.The oled screen turned white and would not route to a different screen.There was an image loss and it remained lost.The image never returned and the current monitor is no longer usable.To complete the procedure, there was another oled hanging in the room, and the procedure was finished with that monitor.This caused a delay of about 10 minutes.
Additional Manufacturer Narrative
Alleged failure: there was a delay in case, as the current monitor is no longer usable.Update - the device is the primary monitor.The oled screen turned white and would not route to a different screen.There was an image loss and it remained lost.The image never returned.To complete the procedure, there was another oled hanging in the room, and the procedure was finished with that monitor.This caused a delay of about 10 minutes the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be monitor settings or setup issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG 32IN 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23186996
• Report Number: 0002936485-2025-00813
• Device Sequence Number: 9843353
• Product Code: FWB
• UDI-Device Identifier: 07613327592146
• UDI-Public: 07613327592146
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/24/2025

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 Catalogue Number: 0240031300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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