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

Catalog Number 72200873S

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 01/21/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation of the returned device confirmed to be serial number (b)(4).A visual inspection was performed on the exterior of product and no damage was found.Product failed functional testing with alarm sounding and "short circuit detected" error message on display.Cause of alarm and error is a defective main pcb.Resistor r54 is burnt and transistors q9 and q10 are shorted out on main pcb.Electronic component failure could have been caused by a shorted out hand piece or plugging in a wet hand piece connector.(b)(4).

Event Description

During an unknown procedure the svce rep, dyonics power ii control unit while using the electrical cord got hot at time of failure.During the case it started smoking very badly.Got another unit and continued the case.

• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4950823
• MDR Text Key: 23133709
• Report Number: 1643264-2015-00087
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2010
• 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