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

Model Number	0406-650-205
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending return of the device.No lot number provided.
Event or Problem Description
On (b)(6) 2023 the uk facility has received a customer complaint from the customer stryker regarding: - it was reported that the patient was burned by the grounding pad, burned noticed when pad was removed.Addtional treatment may need to be provided.Unknown what degree of burn.Patient has been scheduled for a skin graft.No lot provided.Customer states the device will be returned for evaluation.To date, no return received.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLGIES 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 T HP; UK TQ4 THP
• Manufacturer Contact: jessica potter ; 400 exchnage st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 16848652
• Report Number: 3008933393-2023-00008
• Device Sequence Number: 18054364
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: 15060842920029
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/01/2023

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 Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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