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	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an emergency surgical procedure (laparoscopic appendectomy), the surgical team identified a loose piece of rubber in the abdominal cavity.This fragment originated from a puncture in the stopper of the 0.9% nacl irrigation solution bag (ref (b)(4) and batch 25493767) during connection to the stryker ahto irrigation tubing (ref (b)(4), batch unknown).The fragment was retrieved.During the procedure, when a second bag of the same reference number was punctured, the core sampling phenomenon was observed once again.The fragment spilled out with the nacl solution whilst filling a cup.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: 25383650
• Report Number: 0002936485-2026-00357
• Device Sequence Number: 10410540
• Product Code: GCX
• UDI-Device Identifier: 37613327061650
• UDI-Public: 37613327061650
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 07/23/2026; Not provided
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/17/2026; 08/21/2026
• 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