MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB,CONTROL UNIT, DYONICS 25; ARTHROSCOPE

Catalog Number 7211010

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 01/17/2014

Event Type  malfunction  

Manufacturer Narrative

Device was returned and complaint of burning smell was confirmed.Cause of burnt smell is capacitor c58 on motor controller pcb.Cap c58 is on the motor drive ground line.See attachment for pictures of c58.Unit requires non-warranty service and repair.No further investigation is warranted and smith & nephew will continue to monitor for future occurrences of this failure types.(b)(4).

Event Description

It was reported that during a knee procedure using an arthroscope, that there was smoke before the case the unit was smoking and smelled of burning electronics.A backup device was available to complete the procedure.(b)(4).

• Brand Name: RFB,CONTROL UNIT, DYONICS 25
• Type of Device: ARTHROSCOPE
• 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 ; 5123585706
• MDR Report Key: 5012181
• MDR Text Key: 24529271
• Report Number: 1643264-2015-00122
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211010
• Device Lot Number: ZN03222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2008
• 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