MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. SINGLE SPIKE TUBE SET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070530
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	12/17/2024
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 was found inside the sterile packaging.
Event or Problem Description
It was reported that foreign material was found inside the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: it was reported by the customer that "there was a small blue piece of material within the sterile packaging".The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be flash, or the packagers hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG. SINGLE SPIKE TUBE SET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 21153831
• Report Number: 0002936485-2025-00028
• Device Sequence Number: 13035859
• Product Code: GEI
• UDI-Device Identifier: 37613327061353
• UDI-Public: 37613327061353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963646
• 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): 03/21/2025

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: 0250070530
• Device Lot Number: 24123FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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