MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LIMITED STRYKER; NEUTRAL ELECTRODE

Model Number	0406-650-205
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr for the lot was reviewed with no identified non-conformances to raw material or production processes while the device was being built.Based on the information available, the ifu was not followed as it states to check the electrode for contact with skin (especially after moving patient) since it is not monitored by the hf-generator.
Event or Problem Description
The customer called in to report a patient sustained a grade 1-2 burn on the skin where the grounding pad was placed - upper leg/thigh.Lumbar radiofrequency, pad placed on thigh, patient moved during the procedure.The pad was relocated to calf after patient moved.Pad was relocated with no further incident.Medication was provided to treat the burn sustained.Since medical internvention was required nmt has determined this to be a reportable event.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 T HP G; UK TQ4 THP GB
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES; torbay business park; woodview rd; paignton, devon TQ4 7 HIP; UK TQ4 7HIP
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 19491526
• Report Number: 3008933393-2024-00007
• Device Sequence Number: 20589212
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: (01)15060842920029(17)260123(10)068967
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K203494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2026
• Device Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Device Lot Number: 068967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown