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 Codes	Leak/Splash (1354); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
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 the device leaked and was not secure and falling apart.The staff had to deal with a loss in pressure and therefore slower suction rate of fluid out of the patient.
Event or Problem Description
It was reported that the device leaked and was not secure and falling apart.The staff had to deal with a loss in pressure and therefore slower suction rate of fluid out of the patient.
Additional Manufacturer Narrative
The device was discarded and not returned for investigation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: leakage probable root cause for leak: 1.Material/design error 2.Constant irrigation flow is not maintained leading to limited field of view 3.Stopcocks in improper configuration 4.Large anatomy 5.Missing o-ring 6.Damaged or deformed o-ring 7.Pump malfunction (motor, control board, harness, power supply, battery, or cassette) 8.Clogged tubing 9.User error probable root cause for piece broken off, loosened, or missing (i.E.Button, screw, probe tip, etc.: 1.Material/design error 2.Excessive user force 3.Severe shipping conditions 4.Disposable tip rubbing against product 5.User error the reported failure mode will be monitored for future reoccurrence.

• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23375168
• Report Number: 0002936485-2025-00882
• Device Sequence Number: 8915471
• Product Code: GCX
• UDI-Device Identifier: 37613327061490
• UDI-Public: 37613327061490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/22/2025

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: 25013FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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