MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP, DYONICS POWER II CONTROL UNIT; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200873S

Device Problem Device Emits Odor (1425)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Zip code: (b)(6).No evaluation conducted to date, awaiting receipt of device.(b)(4).

Event Description

It was reported that before a procedure, the device presented a short circuit message and smelled of smoke.A backup device was available to start and complete the procedure.No patient injury or complications were reported.

Manufacturer Narrative

A service replacement dii control unit was received and a visual inspection was performed on the exterior of product and no damage was observed.Product failed functional testing with alarm sounding and "short circuit detected" error message.Cause of error is shorted electronic components on the main pcb.The complaint investigation has concluded that the root cause was determined to be that this unit has succumbed to an electrical component failure.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: SVCE REP, DYONICS POWER II CONTROL UNIT
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5910599
• MDR Text Key: 54158023
• Report Number: 1643264-2016-00154
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200873S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1