MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG. ASSY. STRYKEFLOW 2 WITH TIP; Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Catalog Number	0250070520
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the buttons are sticking.The procedure was a laparoscopic cholecystectomy for cholecystitis.Per the report, "the suction has a lag time of activation and also continues to suction after the intended time".Loss of insufflation was confirmed.
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.

• Brand Name: PKG. ASSY. STRYKEFLOW 2 WITH TIP
• Common Device Name: Apparatus, Suction, Operating-Room, Wall Vacuum Powered
• 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: 50707403
• Report Number: 0002936485-2026-00943
• Device Sequence Number: 15966792
• Product Code: GCX
• UDI-Device Identifier: 37613327061360
• UDI-Public: 37613327061360
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/10/2026

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: 0250070520
• Device Lot Number: 108243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 280 LB