MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG CONNECTED OR HUB BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0240200100
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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 oobf hub keeps having issues after previous repair, all sources stop working, window pops up some system services have stopped working please reboot and contact stryker tech support.Slight delay 5 minutes.All the sources randomly fell off the hub.They would continually get the spinning wheel and would have to reboot.Once they go to sources to route nothing is there.When they hit new case get the wheel again.Procedure completed using a video tower.Hence there was a loss of image.
Additional Manufacturer Narrative
Alleged failure: oobf hub keeps having issues after previous repair, all sources stop working, window pops up some system services have stopped working please reboot and contact stryker tech support.Slight delay 5 minutes.All the sources randomly fell off the hub.They would continually get the spinning wheel and would have to reboot.Once they go to sources to route nothing is there.When they hit new case get the wheel again.Procedure completed using a video tower.The failures identified in the investigation is consistent with the complaint record.Probable root cause can be attributed to a software failure.Reinstalling the software fixed the issues.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that oobf hub keeps having issues after previous repair, all sources stop working, window pops up some system services have stopped working please reboot and contact stryker tech support.Slight delay 5 minutes.All the sources randomly fell off the hub.They would continually get the spinning wheel and would have to reboot.Once they go to sources to route nothing is there.When they hit new case get the wheel again.Procedure completed using a video tower.Hence there was a 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 24322300
• Report Number: 0002936485-2026-00089
• Device Sequence Number: 21291098
• Product Code: GCJ
• UDI-Device Identifier: 07613327413281
• UDI-Public: 07613327413281
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/15/2026

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: 0240200100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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