MAUDE Adverse Event Report: NICO CORPORATION MYRIAD HANDPIECE; TISSUE MORCELLATOR

Model Number NN-8004

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/11/2014

Event Type  malfunction  

Event Description

No patient injury occurred as a result of this product problem.The outer cannula on the myriad handpiece is closed on the end by a cap that is welded into place.This welding process consists of two steps.The first step is to tack weld the cap onto the cannula to maintain its position.The second step is to create a more robust weld around the circumference of the cannula/cap assembly which is fully penetrative.The device problem which occurred on (b)(6) 2014 involved a myriad handpiece with a cap which was only tacked into place and was not fully welded to the cannula (i.E.Absence of the final weld).As a result, the cap partially separated from the cannula during clinical use.The handpiece was removed from the surgical site and the cap was still attached to the handpiece - it was not left behind within the patient.

Manufacturer Narrative

Internal evaluation primarily consisted of visual inspection of the outer cannula, the cap, and the weld which joins these two components.It was immediately apparent that only the initial tack welds had been performed and that the final weld was absent.Photos were taken and are on file - they were available upon request.As of the date of this mdr, there have been over 4,500 uses of the myriad handpiece.The cap separation described within this report is the only such failure to date, making this failure remote (1/4500 = 0.02%).

• Brand Name: MYRIAD HANDPIECE
• Type of Device: TISSUE MORCELLATOR
• Manufacturer (Section D): NICO CORPORATION; indianapolis IN
• Manufacturer Contact: jay dittman ; 250 east 96th st.; suite 125; indianapolis, IN 46240 ; 3176607118
• MDR Report Key: 3963688
• MDR Text Key: 4626121
• Report Number: 3007456622-2014-00001
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: K955168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Model Number: NN-8004
• Device Catalogue Number: NN-8004
• Device Lot Number: 1714940
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other