MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS ENERGY 90-S CRUISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 0279401200

Device Problems Continuous Firing (1123); Sparking (2595)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the device continuously activated and sparked.

Event Description

It was reported that the device continuously activated and sparked.

Manufacturer Narrative

Alleged failure: continuous current without operating the footstep / probe with sparking at the electrode.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be an electrical short internal to the ceramic (location unable to be observed during a visual inspection, requires milling of ceramic to verify) or an error with the associated console used during surgery.The probe button stuck.A footswitch also can be used to activate the rf probe, therefore, the use of the footswitch can also be considered a possible root cause.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: SERFAS ENERGY 90-S CRUISE
• 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: 16335244
• MDR Text Key: 309166687
• Report Number: 0002936485-2023-00105
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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: 0279401200
• Device Catalogue Number: 0279401200
• Device Lot Number: 22229AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1