MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYSTEM, U.K., DYONICS POWER II; ARTHROSCOPE

Catalog Number	72201034
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during set up, the dyonics power system was plugged into a storz camera stack and it made bang and set fire to the stack.A non-significant delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluated revealed a loud bang when the device was being powered up.The device wouldn't turn on afterwards.The fuses were replaced and the same outcome happened followed by an electric spark in the power source port.It was determined the power supply was defective.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was associated with electrical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a power supply failure or a defective system controller pcb.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.

• Brand Name: SYSTEM, U.K., DYONICS POWER II
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15674693
• Report Number: 1643264-2022-00387
• Device Sequence Number: 20443999
• Product Code: HRX
• UDI-Device Identifier: 03596010615411
• UDI-Public: 3596010615411
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72201034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown