MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; HOOK ELECTRODE

Model Number	LA8505
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their right angled hook electrode broke and was charred.Another device was utilized to complete the procedure.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the reported event was discarded by the user facility and not returned to the supplier for evaluation.Without the returned device, a root cause of the reported event could not be determined.The right angled hook electrode ifu states, "there is a risk of injury if active electrodes come into contact with other conductive devices and accessories.Keep electrical connections dry while in use to prevent unintended conduction of hf current.Do not activate instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling.The surface of the active electrode may remain hot enough to cause burns after the rf current has been deactivated." a steris account manager provided in-service training on the proper use and operation of the right angled hook electrode.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: V. MUELLER
• Common Device Name: HOOK ELECTRODE
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22873742
• Report Number: 1527821-2025-00017
• Device Sequence Number: 20277622
• Product Code: GEI
• UDI-Device Identifier: 10885403053894
• UDI-Public: (01)10885403053894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Model Number: LA8505
• Device Catalogue Number: LA8505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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