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 Known Impact Or Consequence To Patient (2692)

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 a polypectomy procedure, the device presented a burning smell and smoke.The surgeon removed the remainder of the polyp with forceps.No patient injury or complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device investigation narrative - a truclear control unit part number 7209808 was received on may 23, 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 failed functional testing with an intermittent display and e6 blade stall error message being presented.The cause of the error message and burned 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 december 31, 2014.Udi: (b)(4).Device returned for evaluation.(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: 5673540
• MDR Text Key: 45854004
• Report Number: 1643264-2016-00074
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/23/2016; 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• 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