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

Catalog Number	0240300100
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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 image goes black in a case and they had to restart the tower.Issue was noticed during the case and there was full loss of image for a minute or two and it caused surgical delay for 1-2 minutes.
Event or Problem Description
It was reported that the image goes black in a case and they had to restart the tower.Issue was noticed during the case and there was full loss of image for a minute or two and it caused surgical delay for 1-2 minutes.
Additional Manufacturer Narrative
Alleged failure: per rep: they had the image go black in a case and had to restart tower.Update: issue was noticed during the case.There was full loss of image for a minute or two and it caused surgical delay for 1-2 minutes.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root cause can be attributed to a software issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23374523
• Report Number: 0002936485-2025-00878
• Device Sequence Number: 18624787
• Product Code: GCJ
• UDI-Device Identifier: 07613327562750
• UDI-Public: 07613327562750
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/11/2025

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: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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