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

Catalog Number	0475100000I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
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 there was a thermal event with the product.
Event or Problem Description
It was reported that there was a thermal event with the product.
Additional Manufacturer Narrative
Please note that the product details have been updated with the correct device information.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: surgery (b)(6) from the (b)(6) hospital informed to sale rep that crossfire-2 rf- malfunction in use.Rf probe stopped to work during operation.Surgeon noticed melting in console rf-connector.They changed the console and continued operation.No harm for patient.It took 5 minutes extra time for operation.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be receptacle board, rf probe, or a fluid ingress.

• Brand Name: CROSSFIRE 2 CONSOLE INTERNATIONAL KIT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8461272
• Report Number: 0002936485-2019-00124
• Device Sequence Number: 1341440
• Product Code: GEI
• UDI-Device Identifier: 07613327058086
• UDI-Public: 07613327058086
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 06/06/2019

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: 0475100000I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1