MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR ULTRA RECIPROCATING MORC. 4.0; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72203012

Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/30/2013

Event Type  malfunction  

Event Description

Sales representative stated the doctor admitted to applying too much torque while using the morcellator.A piece of the morcellator broke off during the case and the doctor was able to retrieve it and use a new morcellator to finish the case.No product will be returned.

Manufacturer Narrative

Device was not available to return to manufacturer.(b)(4).

• Brand Name: TRUCLEAR ULTRA RECIPROCATING MORC. 4.0
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jams gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4845109
• MDR Text Key: 15139786
• Report Number: 3003604053-2015-00033
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: 72203012
• Device Lot Number: A60529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1