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

Catalog Number	0279401200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 wand remained "on" with sound coming from the console when a button was not being pressed on the foot pedal or on the hand piece.The device was exceptionally hot to the touch on the handle and removed from the field and disposed of.
Additional Manufacturer Narrative
The device was disposed and will not be returned for investigation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: wand remained on.Probable root cause: probe short, button stuck on firing position, fluid ingress, suction tube cut, button inadvertently pressed, damaged insulation, inadequate gluing operations (tip and core/lumen) or inadequate gluing/welding of core to handle console error.Use errors : incorrect power level set.Nonbendable probe bent with probe bender, or a bendable probe bent with anything other than the stryker rf probe bender.Inserting or withdrawing probe during application of power.Activating the probe while in contact with metal objects or instruments.Probe handle is submerged in liquid or suction tube is cut.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the wand remained "on" with sound coming from the console when a button was not being pressed on the foot pedal or on the hand piece.The device was exceptionally hot to the touch on the handle and removed from the field, and disposed of.

• Brand Name: SERFAS ENERGY 90-S CRUISE
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22331754
• Report Number: 0002936485-2025-00581
• Device Sequence Number: 18480377
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160050
• 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): 09/10/2025

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: 0279401200
• Device Lot Number: 25051AE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown