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

Catalog Number 0475100000

Device Problems Sparking (2595); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

Per additional information received, it was reported that the device made a popping sound and there was a spark.

Manufacturer Narrative

Alleged failure: cib colten, rep, the unit exploded.Po temp 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.Manufacture date is not known.

Event Description

Per additional information received, it was reported that the device made a popping sound and there was a spark.

• 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
• MDR Report Key: 9161989
• MDR Text Key: 168798958
• Report Number: 0002936485-2019-00452
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327058109
• UDI-Public: 07613327058109
• Combination Product (y/n): N
• PMA/PMN Number: K071859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 0475100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1