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

Catalog Number	0240200100
Medical Device Problem Codes	Computer Software Problem (1112); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was software issue.The cor ii hub 3.2.2 recently started intermittently restarting 2 (affected) out of 5 rooms.Issued recommendation to update to 4.1.2 & turn off wifi system using ethernet and wifi off when the ethernet cord was unplugged, the issue went away.Obviously when the hub was turning off and on, there was a loss of image.There was no patient involvement/impact.
Additional Manufacturer Narrative
It was reported that cor ii hub 3.2.2 recently started intermittently restarting 2 (affected) out of 5 rooms.Issued recommendation to update to 4.1.2 & turn off wifi system using ethernet and wifi off" wo or field service investigation notes are not available.The product was not received at rma for investigation, once received the complaint will reopen and update with investigation results.Also, the device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

• 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: 24700091
• Report Number: 0002936485-2026-00182
• Device Sequence Number: 13306200
• Product Code: GCJ
• UDI-Device Identifier: 07613327413281
• UDI-Public: 07613327413281
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 03/26/2026

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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