MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SDC3 BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0240060100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
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
It was reported that there was loss of image.
Additional Manufacturer Narrative
Alleged failure: user reported losing images on all monitors during surgical procedure.Rebooted sdc, all-in-one device and router.When sdc came back up and control transferred to all-in-one, routing screen was accessible but preview screen was black and sdc remote screen remained black with only the red x in the top right corner of the screen.Surgeon could not take pictures from the field and controls were not accessible to the rn at the all-in-one.Salesforce case number (b)(4).[update - procedure completed with same device(reboot), full loss of image for 2 minutes.] the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be (1) software failure (2) incorrectly shutting down the unit (3) hard drive failure.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of image.

• Brand Name: SDC3 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17170563
• Report Number: 0002936485-2023-00604
• Device Sequence Number: 7066867
• Product Code: GCJ
• UDI-Device Identifier: 07613327056150
• UDI-Public: 07613327056150
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160332
• 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): 02/21/2024

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 Model Number: 0240060100
• Device Catalogue Number: 0240060100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• 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