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	No Display/Image (1183); Capturing Problem (2891)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: sn: (b)(6), pn: 0240200200 per the customer, the hub appears to be fried or corrupt.The console/hub went black, and the surgeon could not capture any images.Visual inspection: no damage or dents detected on the console.No labels or markings.No scratches or scuff marks.The warranty seal was not broken when the product was received.Functional inspection: issue confirmed.Cor-ip test performed.The or hub powers on properly and the display switched over to the external gui successfully, and the application loaded to the main menu.Routing sources were available.Tie lines were detected and applied successfully.A display was present on the primary monitor.Once in the capture menu, unable to capture or record with the camera head.Troubleshooting performed.System settings checked.In the settings/system/case menu, the 1788 check box was turned on.When 1788 check box was turned off, camera head capturing and recording was possible.A quick functional test was performed.The camera head was able to capture images, and record videos.Case file was exported onto a jump drive media.The hub is not fried.Internally, the hub is clear of dust and lint.All components are properly connected, and no physical damage was observed.No software corruption encountered.The or hub boots up and loads to the main menu.No critical errors, abrupt shutdowns, or reboots encountered.The hub did not go black.No black screen encountered while the unit was under test.The or hub as software version 4.1.3.156u.The probable root causes are software, or application settings.The failure identified in the investigation is consistent with the complaint record.However, the issue of loss of image could not be replicated.The probable root causes are software, or application settings.The product was returned for investigation, and the failure mode will be monitored for future recurrence.
Event or Problem Description
It was reported that the console/hub went black and the surgeon could not capture any images.Since the device went black, it is possible that there may have been a full loss of image.
Additional Manufacturer Narrative
Alleged failure: sn: (b)(6), pn: 0240200200 per the customer, the hub appears to be fried or corrupt.The console/hub went black, and the surgeon could not capture any images.The failure identified in the investigation and consistent with the complaint record.The probable root causes are software, or application settings.The product was returned for investigation, and the failure mode will be monitored for future recurrence.
Event or Problem Description
It was reported that the console/hub went black and the surgeon could not capture any images.Since the device went black, it is possible that there may have been a full loss of image.

• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21988208
• Report Number: 0002936485-2025-00420
• Device Sequence Number: 4478506
• Product Code: GCJ
• UDI-Device Identifier: 07613327601695
• UDI-Public: 07613327601695
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K222079
• 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): 06/20/2025

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: 0240200200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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