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	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 19th january 2023 received a customer complaint as follows: it was reported that the patient suffered a burn at the grounding pad site.Burn was not discovered until after procedure was done.There may have been a blister, but not confirmed, considered 2nd degree burn.A bandage and ointment was used on the burn.Customer sent generator back and sales rep will try to secure ground pad we do not know the lot/serial number.Doctor stated the grounding pad placement and prep may have been an issue.Cases before and after this one were completed without incident.There was no reported issues with the generator.Due to the medical intervention to preclude impairment, nissha medical technologies limited has found this to be a reportable event.
Additional Manufacturer Narrative
No lot number provided therefore no evaluation of the production records could be performed.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview road; paignton, devon TQ47H P; UK TQ47HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 16372138
• Report Number: 3008933393-2023-00002
• Device Sequence Number: 20536559
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: 15060842920029
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: 70000856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/14/2023
• 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