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	Burn(s) (1757)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
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 grounding pad burned the patient during the procedure.Occurred on (b)(6) 2023.Stryker grounding pad that was ordered for mg2 rf generator burned pt leg during procedure incident occurred during procedure.Pt was burned on back of left thigh.Pt was given antibiotic cream and physician will monitor.No delay.Procedure was completed successfully.The skin prep to the neck and pack was clear chloraprep.The skin prep to the grounding pad site was none.Pt.Had some hair, but not excessive.Customer states they were not given the updated recommendations for these grounding pads until after the incident.The generator did not malfunction.The settings were on 85 degrees celsius for 90 seconds.Md dictated second degree burn.Due to the mdical intervention to preclude impairment, nissha medical technologies limited has found this to be a reportable event.
Additional Manufacturer Narrative
The production record was reviewed and there were no atypical events or occurrences that could account for this event.Information provided by the customer was reviewed.They have confirmed that the pad was incorrectly orientated when compared to the instructions for use.It is concluded that the cause of this event is failure to follow the instructions for use.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• 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 exchange street; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 16491246
• Report Number: 3008933393-2023-00004
• Device Sequence Number: 17872326
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: 15060842920029
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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 Expiration Date: 10/13/2025
• Device Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Device Lot Number: 068956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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