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

Catalog Number	0475000100
Medical Device Problem Code	Continuous Firing (1123)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
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 the device caused continuous activation.
Additional Manufacturer Narrative
Alleged failure: pedals sticking, staying in mode.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be an issue related to different product attachments, such as the handpiece or rf probes.An error with the associated console used during surgery.Footswitch fatigues over time, footswitch defect, loose disconnected cable.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device caused continuous activation.

• Brand Name: PKG, CROSSFIRE FOOTSWITCH
• Common Device Name: 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: 17446569
• Report Number: 0002936485-2023-00749
• Device Sequence Number: 7347690
• Product Code: GEI
• UDI-Device Identifier: 07613327058093
• UDI-Public: 07613327058093
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K071859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0475000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown