MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FOUR SPIKE IRRIGATOR SET EACH - ORDER MULTIPLES OF 10; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0350195004
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	08/10/2025
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 a foreign object was identified inside the sterile packaging when setting up room.
Additional Manufacturer Narrative
Alleged failure: foreign object identified inside the sterile packaging when setting up room.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be inadequate packaging and cleaning operations.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that a foreign object was identified inside the sterile packaging when setting up room.

• Brand Name: FOUR SPIKE IRRIGATOR SET EACH - ORDER MULTIPLES OF 10
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23091062
• Report Number: 0002936485-2025-00788
• Device Sequence Number: 15873812
• Product Code: GCJ
• UDI-Device Identifier: 37613327061643
• UDI-Public: 37613327061643
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 0350195004
• Device Lot Number: 25083FE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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