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

Catalog Number 0475100000

Device Problems Electrical Shorting (2926); Activation Failure (3270)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Per investigation results, the device had blown components resulting in the potential for a thermal event.

Manufacturer Narrative

Alleged failure: it was reported that the crossfire 2 displayed an e41 error code immediately upon being opened and plugged in.This was an out of box failure.The failure(s) identified in the investigation is consistent with the complaint record.The root cause is the power board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 17575882
• MDR Text Key: 321514004
• Report Number: 0002936485-2023-00838
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 08/18/2023

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: Other
• Device Catalogue Number: 0475100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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