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

Model Number	0406-605-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient came out from or and patient came out with two burns, and patient stated they felt something during the procedure.Patient might need a skin graft or there might be a scar left after wound is healed.Staff applied treatment to protect the wound after the incident.
Additional Manufacturer Narrative
A manufacturing review was completed for the lot in question, with all relevant manufacturing records.No issues were identified during production that could have impacted product quality.There have been no confirmed complaints for this finished good lot or raw material lots.It has not been possible to investigate further as no information regarding skin preparation, pad placement or procedural parameters was able to be provided and therefore use error cannot be ruled out as a contributing factor.

• 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; UK TQ4 THP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 19837445
• Report Number: 3008933393-2024-00008
• Device Sequence Number: 12411706
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: (01)15060842920029(17)261004(10)076042
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 10/04/2026
• Device Model Number: 0406-605-205
• Device Catalogue Number: 700000856
• Device Lot Number: 076042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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