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	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during the procedure, the stryker suction irrigation device broke at the base of the suction tip.No medical intervention or adverse consequences were reported.The procedure was completed successfully.
Additional Manufacturer Narrative
The investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Alleged failure: the sales rep reported, "detailed description of the event: during the procedure, the stryker suction irrigation device broke at the base of the suction tip." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be too much stress put on the handpiece causing it to break off, or the handpiece was dropped.The product was returned for investigation, and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during the procedure, the stryker suction irrigation device broke at the base of the suction tip.No medical intervention or adverse consequences were reported.The procedure was completed successfully.

• 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: 24252857
• Report Number: 0002936485-2026-00054
• Device Sequence Number: 8326646
• Product Code: GCX
• UDI-Device Identifier: 07613327061659
• UDI-Public: (01)07613327061659(17)270925(10)25268FG2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2026

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: 25268FG2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2026
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/20/2026; 08/30/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/22/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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