MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR CONTROL UNIT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209808

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

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

No evaluation conducted to date, awaiting receipt of device.(b)(4).

Event Description

It was reported that during non-clinical testing, the device presented a burning smell and smoke.No patient involvement.

Manufacturer Narrative

Operator of the device was manufacturer representative.Device investigation narrative - a truclear control unit part number 7209808 was received on may 26, 2016 and confirmed to be serial number (b)(4).A visual inspection was performed and no damage was observed.Complaint of burning smell was confirmed.The device was functional tested and presented an e6 blade stall error message.The cause of the error message and source of burning smell was identified to be associated with a failure of the main circuit board.Factors which could have contributed to the main circuit board failure include a failed motor assembly of the concomitant trueclear hand piece.A review of the manufacturing records show this device was released into distribution on or about january 7, 2014.Device returned for evaluation, device evaluated by the manufacturer, evaluation codes updated.(b)(4).

• Brand Name: TRUCLEAR CONTROL UNIT
• Type of Device: HYSTEROSCOPE (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: 5673910
• MDR Text Key: 45854045
• Report Number: 1643264-2016-00076
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

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: Other
• Device Catalogue Number: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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