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	10/31/2025
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 while using the crossflow, the shoulder pressure was too high.The pressure was set to 35 then 25 but the shoulder expanded larger than it should have.
Additional Manufacturer Narrative
Alleged failure: crossflow - shoulder pressure was too high - pressure was set to 35 then 25 - shoulder expanded larger than it should have.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) inflow cassette not properly inserted.2) improper joint level.3) user settings.4) kinked inflow cassette.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that while using the crossflow, the shoulder pressure was too high.The pressure was set to 35 then 25 but the shoulder expanded larger than it should have.

• 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 ; 4087542000
• MDR Report Key: 23660691
• Report Number: 0002936485-2025-00950
• Device Sequence Number: 10288515
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown