MAUDE Adverse Event Report: MEDLINE RENEWAL STRYKER SERFAS ENERGY PROBES; 279-401-200 SERFAS ENERGY 90-S CRUISE

Catalog Number	279401200RH
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when staff plugged in the serfa wand, the generator said not recognized.Cord was moved to different positions which allowed the device to work and then quickly disconnect saying disconnected.It seemed like an electrical short in the cord.The staff grabbed a new device and finished the case.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that, when staff plugged in the serfa wand, the generator said not recognized.Cord was moved to different positions which allowed the device to work and then quickly disconnect saying disconnected.It seemed like an electrical short in the cord.The staff grabbed a new device and finished the case.

• Brand Name: STRYKER SERFAS ENERGY PROBES
• Common Device Name: 279-401-200 SERFAS ENERGY 90-S CRUISE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25251037
• Report Number: 3032391-2026-00020
• Device Sequence Number: 18573237
• Product Code: NUJ
• UDI-Device Identifier: 10888277700659
• UDI-Public: 10888277700659
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 279401200RH
• Device Lot Number: 562902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 89 KG