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

Catalog Number	0475100000
Medical Device Problem Codes	Sparking (2595); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: error sparks coming out.Additional information: the sparks actually started flying out prior to the procedure when the crossfire was initially plugged in.It was from the area where the cord plugged into the box.Since we caught it prior to the case there was no patient or case involvement.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The root cause is the power board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was an error and sparks coming out.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was an error and sparks coming out.

• 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: 24622475
• Report Number: 0002936485-2026-00159
• Device Sequence Number: 15911210
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/18/2026

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: 02/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2014
• 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