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

Catalog Number 7209807

Device Problem Device Inoperable (1663)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Device has been received, evaluation has not yet begun.(b)(4).

Event Description

During a d&c it was reported that the blade stopped working mid-case.When turned on, it does not run.The procedure was completed by use of a standard curettage instrument.No patient injuries or complications were reported.

Manufacturer Narrative

Functional testing found that the motor runs rough and seizes intermittently.Upon disassembly and inspection, the front end seal assembly was found to be rusted and corroded causing the intermittent operation.A review of the device documentation shows that this serial number was manufactured in february of 2015 and no deficiencies were noted.Rust and corrosion to this degree is unusual for a unit that is less than a year old.Improper routine or preventative maintenance is attributable to the event.

• 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: 5184617
• MDR Text Key: 30226347
• Report Number: 1643264-2015-00169
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

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
• Device Lot Number: YE02943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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