MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG CROSSFIRE 2 CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0475100000
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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 fuse of the console blew during a case, causing a popping sound and affecting video/tower function.There was no patient involvement, but a new unit needed to be brought in, and the tower needed to be restarted.
Additional Manufacturer Narrative
Alleged failure: per our on-site team member and ortho lead, the fuse of the console blew during a case today, causing a popping sound and affecting video/tower function.There was no patient involvement, but a new unit needed to be brought in, and the tower needed to be restarted.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be due to fluid ingress and/or physical damage.It is recommended to swap this console for a new one.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the fuse of the console blew during a case, causing a popping sound and affecting video/tower function.There was no patient involvement, but a new unit needed to be brought in, and the tower needed to be restarted.

• Brand Name: PKG CROSSFIRE 2 CONSOLE
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23660127
• Report Number: 0002936485-2025-00945
• Device Sequence Number: 15983480
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• 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): 01/20/2026

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: 0475100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown