MAUDE Adverse Event Report: Stryker Endoscopy-San Jose CROSSFLOW DAY-USE INFLOW CASSETTE TUBING EACH - ORDER MULTIPLES OF 10; arthroscope

Catalog Number	0450000115
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction

• 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 ; +1(408)754-2000
• MDR Report Key: 50058142
• Report Number: 0002936485-2026-00523
• Device Sequence Number: 10730545
• Product Code: HRX
• UDI-Device Identifier: 37613327261029
• UDI-Public: 37613327261029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151932
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0450000115
• Device Lot Number: K25F143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 56 YR
• Patient Sex: Male