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

Catalog Number	0450000000
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
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 during shoulder arthroscopy there was no pressure build-up with the default settings on the crossflow pump and a daily cassette in inflow-outflow mode.The tubing systems were replaced.Initially set to the same batch, but no change in the situation.Only by increasing the pressure (70 mmhg+) and the flow (high) could the procedure be continued.

• 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: 25248003
• Report Number: 0002936485-2026-00321
• Device Sequence Number: 9597377
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: (01)07613327058048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: 0450000000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 08/24/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/24/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2014
• 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