MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKER AHTO TUBE SET PACKAGING; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0250070600
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	02/05/2025
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 foreign material found inside the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: per rep, "i have an account that found a blue item inside their sterile ahto packaging when opening for a case today." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the tyvek cover was dirty or the packagers hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that foreign material found inside the sterile packaging.

• Brand Name: STRYKER AHTO TUBE SET 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21532905
• Report Number: 0002936485-2025-00176
• Device Sequence Number: 8050206
• Product Code: GCX
• UDI-Device Identifier: 37613327061490
• UDI-Public: 37613327061490
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 0250070600
• Device Lot Number: 24258FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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