MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SDC4K INFORMATION MANAGEMENT SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0240300100
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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 the hub was updated to 5.2 sw but they are experiencing these issues: inability to consistently toggle insufflator from camera head.4k wireless signal drop intraoperatively.Sdc4k require network credentials upon boot up ¿ not connected to network on boot up.The medical procedure completed by performing a re-sync of the 4k wireless or direct connected to wall plate with dvi cable.Duration of full loss of image on primary monitor - complainant not aware.
Additional Manufacturer Narrative
The sales representative confirmed that the device will not be 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: no live video output.Probable root cause: hardware: cables, connectors, sources, or sinks, capture card, motherboard, power supply, thunderbird firmware.Software: thunderbird software use error.Others: manufacturing defects (process, workmanship) cybersecurity (see rsk14010) video input/output over-heating (air duct, fans, heat sinks, dust, vents).The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the hub was updated to 5.2 sw but they are experiencing these issues: inability to consistently toggle insufflator from camera head.4k wireless signal drop intraoperatively.Sdc4k require network credentials upon boot up ¿ not connected to network on boot up.The medical procedure completed by performing a re-sync of the 4k wireless or direct connected to wall plate with dvi cable.Duration of full loss of image on primary monitor - complainant not aware.

• Brand Name: SDC4K INFORMATION MANAGEMENT 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23032060
• Report Number: 0002936485-2025-00776
• Device Sequence Number: 9454867
• Product Code: GCJ
• UDI-Device Identifier: 07613327562750
• UDI-Public: 07613327562750
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K220108
• 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): 10/14/2025

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: 0240300100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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