MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG CROSSFLOW CONSOLE; arthroscope

Catalog Number	0450000000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of the shoulder arthroscopy procedure, the patient was flipped supine on the operating room table, and noticeable fluid swelling was observed on the patient's operative side neck and through his entire chest.It was then decided to transfer the patient to the icu until the airway swelling went down and could be safely extubated.The patient unable to be discharged as originally scheduled as they needed to be reintubated and sent to the icu.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: PKG CROSSFLOW CONSOLE
• Common Device Name: arthroscope
• 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: 50063461
• Report Number: 0002936485-2026-00541
• Device Sequence Number: 18419573
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K123441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown