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

Catalog Number 7209808

Device Problem Smoking (1585)

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

Event Date 09/19/2014

Event Type  malfunction  

Event Description

During a dnc hysteroscopy, it was reported that the control unit for the hysteroscopic morcellator handpiece began smoking when plugged in together.It was reported that there was not a backup device available during the procedure.In order to remove the polyp, the surgeon proceeded through the working channel with a scope and a pair of graspers to complete the case.

Manufacturer Narrative

Subject device was received and evaluated.The reported complaint has been confirmed.Truclear control unit has an odor of burnt electronic components.A visual inspection has found two burnt diodes on the main circuit board.Evaluation of the subject device has concluded user error.It was recommended that the user refer to the cable replacement instructions that can be found in the hysteroscopic morcellation system ifu (instruction for use).Unit will require non-warranty repair.Per results of the investigation, the root cause has been determined to be hand piece pins bent due to user error.At this time, no further investigation will be implemented.(b)(4).

• Brand Name: SMITH & NEPHEW HYSTEROSCOPIC MORCELLATOR SYSTEM CONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4851594
• MDR Text Key: 5937788
• Report Number: 1643264-2015-00026
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

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: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1