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	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The production record was reviewed and there were no atypical events or occurrences that could account for this event.One ncr was opened against the raw material lot y44 used on this batch, this resulted in an evaluation that finally concluded that any neutral electrodes manufactured using lot y44 were fully conforming to the specifications of iec 60601-2-2.With this conclusion and the available details from the adverse event it is determined that there is no causal link between this ncr and the adverse event.Furthermore, there are no other atypical events or occurrences during production that suggest a product quality issue with the neutral electrode.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.
Event or Problem Description
On 27th january 2023 received a customer complaint regarding: it was reported that during a procedure the patient received a minor burn on the skin.The patient was burned on the skin.It is a 2 inch burn along the ground pad.The ground pad was placed on the patient's left thigh and extended along the cross of the knee.The patient was prone (face down) and the pad was placed on the backside of the hamstring, with part of the pad extending across the crease in the backside of their knee.Several pads from the same lot used in earlier cases and after this case without any issues.Patient sustained 2nd degree burns and was treated with cream.Due to the medical intervention to preclude impairment, nissha medical technologies limited has found this to be a reportable event.

• Brand Name: STRYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview road; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; wood view rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: jessica potter ; 400 exchange st; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 16372636
• Report Number: 3008933393-2023-00003
• Device Sequence Number: 12449793
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: 15060842920029
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 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: Not provided
• 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