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

Model Number	0406-650-205
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to nmt on(b)(6) 2024 by the sales rep that a patient was burned by a grounding pad.Patient was prescribed burn medication.Sales rep stated the site prep was done but the pad was placed on the calf in a vertical orientation.Burn was said to be 1st degree.The surgery was completed successfully.
Additional Manufacturer Narrative
A manufacturing review was completed using all associated records for production of lot 073082.This did not highlight any issues with the lot or raw material used.Furthermore, there have been no confirmed complaints against this lot or the raw material lot.In the complaint report it was stated that the pad was positioned in a vertical orientation on the calf.This is contrary to the ifu instructions which requires the long edge of the pad to face the surgical site, and additionally states that the thigh is the preferred location on the leg.Application of the product in this way can affect the current distribution across the pad and therefore is more likely to result in increased temperature at the skin surface.The cause is therefore assigned as use error.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL LTD; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 19289803
• Report Number: 3008933393-2024-00004
• Device Sequence Number: 8739686
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: (01)15060842920029(17)260420(10)073082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 04/20/2026
• Device Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Device Lot Number: 073082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/10/2024
• 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