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	No Display/Image (1183); Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hub connected to a corlite system alerted that it was overheating and would shut down due to heat.The account then had 45 seconds before the hub powered down.This hub is not in an enclosed space and to be honest its probably given some of the best clearance from other objects in an or space that he have seen.Hub was off when he visited and was not hot to touch.Image loss due to corlite setup no longer being able to route through hub during case.Backup signal utilized and that worked fine.Unsure of duration of loss of image.Likely until they was able to remind them of their backup signal on monitor 1 in the room.Procedure was completed using backup signal directly to monitor 1 from endocamera control unit.Therefore, there was a thermal event and loss of image.
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 ; 4087542000
• MDR Report Key: 25172991
• Report Number: 0002936485-2026-00294
• Device Sequence Number: 21377948
• Product Code: GCJ
• UDI-Device Identifier: 07613327413281
• UDI-Public: 07613327413281
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/11/2026

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: 04/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• 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