MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG. ASSY. SUCTION IRRIGATOR 2; Laparoscope, General & Plastic Surgery

Catalog Number	0250070500
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction

• Brand Name: PKG. ASSY. SUCTION IRRIGATOR 2
• Common Device Name: Laparoscope, General & Plastic Surgery
• 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: 25784117
• Report Number: 0002936485-2026-00463
• Device Sequence Number: 9545470
• Product Code: GCJ
• UDI-Device Identifier: 37613327061391
• UDI-Public: (01)37613327061391(17)280220(10)26051FG2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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: 0250070500
• Device Lot Number: 26051FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/03/2026; 09/03/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/30/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• 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