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

Catalog Number	0475100000
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during a shoulder scope, the crossfire started reading ¿expired product¿ when the wand and shaver were plugged in even though the products were not expired.Unfortunately, the doctor could not finish the scope and had to perform an open repair.Doctor had to stop the scope and finish the procedure open, creating a large incision with different tools.Case was delayed 20 minutes or more.
Additional Manufacturer Narrative
Alleged failure: during a shoulder scope, the crossfire started reading ¿expired product¿ when the wand and shaver were plugged in even though the products were not expired.The account burned 3 wands and 2 shavers to try to fix the problem.They also switched out a different hand piece and different crossfire console which would not fix the problem.Unfortunately, the doctor could not finish the scope and had to perform an open repair.Doctor had to stop the scope and finish the procedure open, creating a large incision with different tools.Case was delayed 20 minutes or more the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.No problem found.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during a shoulder scope, the crossfire started reading ¿expired product¿ when the wand and shaver were plugged in even though the products were not expired.Unfortunately, the doctor could not finish the scope and had to perform an open repair.Doctor had to stop the scope and finish the procedure open, creating a large incision with different tools.Case was delayed 20 minutes or more.

• 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: 24098320
• Report Number: 0002936485-2026-00029
• Device Sequence Number: 10397438
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown