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

Model Number	0406-650-205
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing review was completed using all associated records for production of lot 068964.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.The complaint reports states that the skin was not shaved per ifu' and therefore this complaint can be determined to be a use error with the currently provided information.
Event or Problem Description
The customer reported "when i removed the grounding pad, i saw that patient had about 5 focal spots of skin burns, with red and yellow discoloration, consistent with second degree burn." the procedure was complete but the patient had complained of burning during the procedure and then identified a burn after the procedure.The skin was not shaved per the ifu.However the customer stated they normally don't shave and have never had this issue.The pad was oriented and positioned on the thigh according to the ifu.Customer reported "patient was treated with intramuscular toradol, ice pack and topical silver sulfadiazine.Patient was discharged with ice packs, and silver sulfadiazine.Today i called the patient and he states the pain is under control, but he had a blister the size of a quarter which had burst since medical intervention was involved, nmt has deemed this a reportable event.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLGIES LTD; torbay business park; woodview rd; paington, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14204 ; 7169461686
• MDR Report Key: 19179174
• Report Number: 3008933393-2024-00003
• Device Sequence Number: 7412802
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: (01)15060842920029(17)251202(10)068964
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/25/2024

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: 12/02/2025
• Device Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Device Lot Number: 068964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/25/2024
• 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