MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP DYONICS POWER II CONTROL UNIT; ARTHROSCOPE

Catalog Number 72200873S

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2019

Event Type  malfunction  

Event Description

It was reported that when the surgical team plugged the wand into the port, the device turned on running continuously unintended.The event occurred before the procedure.No patient involved.There were no injury to the user.

Event Description

It was reported that when the surgical team plugged the wand into the port, the controller made the wand to turned on running continuously unintended.The event occurred before the procedure.No patient involved.There were no injury to the user.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.Complaint of electrical short could not be reproduced.Product passed functional testing and 6 hour burn-in enclosed test tower.Unit did not spark or short out during functional testing on both ports.All functions perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: SVCE REP DYONICS POWER II CONTROL UNIT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8852960
• MDR Text Key: 153092813
• Report Number: 1643264-2019-00514
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1