MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW DAY-USE INFLOW CASSETTE TUBING EACH - ORDER MULTIPLES OF 10; ARTHROSCOPE

Catalog Number	0450000115
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the pump set up and priming were all done correctly.With the pump set at 40mm we started the case.The patient's knee started to blow up almost immediately.We stopped and got a different pump and switched the tubing cartridge to the second pump.Same thing was happening.Now i just dropped the pump pressure to 15mm and completed the case with no further issues.The extra swelling dissipated over the next few days post-op with no remaining patient issues.

• Brand Name: CROSSFLOW DAY-USE INFLOW CASSETTE TUBING EACH - ORDER MULTIPLES OF 10
• 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: 24691773
• Report Number: 0002936485-2026-00180
• Device Sequence Number: 10004321
• Product Code: HRX
• UDI-Device Identifier: 37613327261029
• UDI-Public: 37613327261029
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 0450000115
• Device Lot Number: K25A014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown