MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP, CONTROL UNIT ASSEMBLY; ARTHROSCOPE

Catalog Number 7205841

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476); Smoking (1585)

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

Event Date 03/25/2014

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the complaint of burnt odor and power up failure was confirmed.Cause of odor and power failure is burned electronic components on power supply.Unit is over 12 years old.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that during a knee scope procedure using an arthroscope, that there was a burnt odor and power up failure.It was also reported that the unit started smoking.A back up device was used to complete case.(b)(4).

• Brand Name: SERVICE REP, CONTROL UNIT ASSEMBLY
• 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 01810 ; 5123585706
• MDR Report Key: 5011526
• MDR Text Key: 24546400
• Report Number: 1643264-2015-00119
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030196
• 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: 03/25/2014

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: 7205841
• Device Lot Number: WA05542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2001
• 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