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	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hub in an or that is continuously shutting down mid case.The hub would shut down during almost every case however all cases were completed successfully.The estimated loss of image to be around 20 seconds per occurrence.Issues were noticed during procedure when the hub would shut down.The same device was used to complete all cases.No medical intervention was needed.No adverse consequences as visualization come back quickly and media was saved.The estimated delay to be about 5 minutes per case if the hub only shut down once.No patient impact was reported.The hub was reported to have the same event occur 10 times.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• 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 ; +1(408)754-2000
• MDR Report Key: 50060427
• Report Number: 0002936485-2026-00532
• Device Sequence Number: 10656789
• Product Code: GCJ
• UDI-Device Identifier: 07613327413281
• UDI-Public: 07613327413281
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2019
• 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