MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CABLE ASSEMBLY; SAW, POWERED, AND ACCESSORIES

Model Number	7205788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and corrosion was observed between the pins on the connector.A functional evaluation revealed that the cable caused the handpiece to run continuously.The complaint was confirmed and a root cause has been associated with electrical component failure.Factors that could have contributed to the failure include corrosion in the cable assembly from cleaning and sterilization methods and the chemicals involved over a period of time or a short in the cord.
Event or Problem Description
It was reported that the dyonics power cable assembly had a short in the cable.No patient injury reported.

• Brand Name: DYONICS POWER CABLE ASSEMBLY
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7026734
• Report Number: 1643264-2017-01720
• Device Sequence Number: 19068730
• Product Code: HAB
• UDI-Device Identifier: 03596010408990
• UDI-Public: (01)03596010408990
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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 Model Number: 7205788
• Device Catalogue Number: 7205788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1