MAUDE Adverse Event Report: Stryker Endoscopy-San Jose STRYKER AHTO TUBE SET WITH TIP PACKAGING; Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Catalog Number	0250070620
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure using a stryker ahto 250-070-620 irrigation/suction set connected to a b.Braun ecobag 0.9% nacl 3000 ml tubing, the scrub nurse noticed a piece of gray plastic in the cup after purging the system.No serious consequences for the patient.Please note, the nacl irrigation solution bag is not a stryker product.It was alleged that this issue occurred when using the stryker ahto tubeset.
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: STRYKER AHTO TUBE SET WITH TIP PACKAGING
• 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: 50000055
• Report Number: 0002936485-2026-00499
• Device Sequence Number: 13415417
• Product Code: GCX
• UDI-Device Identifier: 37613327061650
• UDI-Public: 37613327061650
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2026

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: 0250070620
• Device Lot Number: unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/27/2026
• 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 Sex: Unknown