MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG CONNECTED OR HUB BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0240200200
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that or hub was on 5.2 sw in integrated room.In the setup they use hub display settings to change the display format of an hdmi output to dvi related settings.With the reboot of the or hub these display format and display profile settings are reverting back automatically to hdmi settings which is causing flickering in the room.Customer wants the display profile and display format settings to stick in future software.They keep getting flickering in this room so they inspected it and figured out that this setting keeps defaulting back even though they want it to stay on the setting they set it to.It just keeps doing it.Sometimes in a minute there would be a lot of flickering within a minute, and sometimes it wouldn¿t flicker for 15 or 20 minutes.Hence there is a loss of image and flickering.
Additional Manufacturer Narrative
Three attempts were made to retrieve the device for evaluation but the device was not returned.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: flickering probable root cause: cables, connectors, sources, or sinks, capture card, motherboard, power supply , sdc firmware, over-heating (air duct, fans, heat sinks, dust, vents), sdc application software [cor, ip], clarity package, clarity algorithm, use error, cybersecurity - assets - video input/output, video routing, teleconferencing/calls/video streaming esp software.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that or hub was on 5.2 sw in integrated room.In the setup they use hub display settings to change the display format of an hdmi output to dvi related settings.With the reboot of the or hub these display format and display profile settings are reverting back automatically to hdmi settings which is causing flickering in the room.Customer wants the display profile and display format settings to stick in future software.They keep getting flickering in this room so they inspected it and figured out that this setting keeps defaulting back even though they want it to stay on the setting they set it to.It just keeps doing it.Sometimes in a minute there would be a lot of flickering within a minute, and sometimes it wouldn¿t flicker for 15 or 20 minutes.Hence there is a loss of image and flickering.

• Brand Name: PKG CONNECTED OR HUB BASE SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 24509753
• Report Number: 0002936485-2026-00142
• Device Sequence Number: 10456648
• Product Code: GCJ
• UDI-Device Identifier: 07613327601695
• UDI-Public: 07613327601695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241401
• 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): 05/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0240200200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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