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

Model Number 7205788

Device Problem Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Event Description

It was reported that the device was short circuiting.No patient injuries were reported.

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 and no deficiencies were observed.A functional test revealed the device caused a "handpiece motor fault" message to be displayed when tested.Current draw exceeded 2 amps.Troubleshooting revealed that cable pin 8 was shorted to the connector housing.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The complaint was confirmed and the root cause was associated with electrical component failure.

• Brand Name: DYONICS POWER CABLE ASSEMBLY
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7682628
• MDR Text Key: 113897510
• Report Number: 1643264-2018-00527
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010408990
• UDI-Public: (01)03596010408990
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205788
• Device Catalogue Number: 7205788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1