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

Catalog Number 7209807

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

Other: 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 upon connection.No patient injury or complications were reported.

Manufacturer Narrative

Device investigation narrative - a truclear mdu, part number 7209807, 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 could not be confirmed but the device caused an e6 blade stall error message.The cause of the blade stall error message was identified to be associated with a failure of the motor assembly.A motor stall condition will result in increased current draw from the control unit.Factors which can contribute to a motor failure include corrosion caused by cleaning and sterilization methods and the chemicals involved.Udi: (b)(4).Device returned for evaluation.(b)(4).

• Brand Name: TRUCLEAR HANDPIECE
• 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: 5673911
• MDR Text Key: 45805510
• Report Number: 1643264-2016-00075
• 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
• 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: Health Professional
• Device Catalogue Number: 7209807
• 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
• Supplement Dates FDA Received: 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