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

Model Number 0475100000

Device Problems Sparking (2595); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was a thermal event and sparking.

Manufacturer Narrative

Alleged failure: it was reported by the sales rep nick bianco serial # (b)(6) was used live in a case for the first time on (b)(6) a 90-s rf wand was plugged into the unit, and when the surgeon deployed the trigger, the unit responded with it's audible cue, and said "cut" on it's display screen, however the wand was not activating the crossfire was rebooted, and the same problem occurred.A new wand was opened, and the same problem the crossfire was rebooted, and the same problem occurred.A new wand was opened, and the same problem serial # (b)(6) there was an audible "pop" and a quick spark was seen inside of the unit through the vents on the side of the console.The ablator continued to work, however there was an odor of electrical smoke.I unplugged this unit and discontinued its use immediately.The failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a thermal event and sparking.

• Brand Name: PKG, CROSSFIRE 2 CONSOLE
• Type of Device: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16964849
• MDR Text Key: 315652943
• Report Number: 0002936485-2023-00479
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 0475100000
• Device Catalogue Number: 0475100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1