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

Catalog Number	0279401200
Medical Device Problem Codes	Continuous Firing (1123); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 during the procedure it was placed in an instrument bag when not in use.A few minutes later, a noise and sparks appeared from the serfas even though it was no longer in use.No one had activated it via the foot pedal or manually.The surgeon urgently picked up the serfas, which continued to spark.We urgently disconnected it to stop this.
Additional Manufacturer Narrative
Alleged failure: it was then placed in an instrument bag when not in use.A few minutes later, a noise and sparks appeared from the serfas even though it was no longer in use.No one had activated it via the foot pedal or manually.The failure(s) identified in the investigation are consistent with the complaint record.The probable root cause is most likely an internal leak due to a broken or damaged bond between the polyimide and suction tubing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during the procedure it was placed in an instrument bag when not in use.A few minutes later, a noise and sparks appeared from the serfas even though it was no longer in use.No one had activated it via the foot pedal or manually.The surgeon urgently picked up the serfas, which continued to spark.We urgently disconnected it to stop this.

• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23842327
• Report Number: 0002936485-2025-00993
• Device Sequence Number: 10030013
• Product Code: GEI
• UDI-Device Identifier: 07613327057034
• UDI-Public: 07613327057034
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/13/2026

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: 25135AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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