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

Model Number 0475100000

Device Problem Activation Failure (3270)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

Alleged failure: eib, kayla, customer, does not work with footpedal or shaver, po# temp the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be the receptacle board, front board, shaver, or footswitch.The product was returned for investigation and the failure mode will be monitored for future re-occurrence.

Event Description

It was reported that there was a thermal event.

• 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: 17083490
• MDR Text Key: 316749071
• Report Number: 0002936485-2023-00563
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2023

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: Health Professional
• Device Model Number: 0475100000
• Device Catalogue Number: 0475100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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