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); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shut down during the case.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: shut down during the case.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root cause can be attributed to issues with the software.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device shut down during the case.

• 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: 22976663
• Report Number: 0002936485-2025-00761
• Device Sequence Number: 9256626
• Product Code: GCJ
• UDI-Device Identifier: 07613327562750
• UDI-Public: 07613327562750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/31/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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