MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR INCISOR PLUS BLADE 2.9; HYSTEROSCOPE AND ACCESSORIES

Catalog Number 72202536

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 03/18/2013

Event Type  malfunction  

Event Description

Patient was safe and there was no fluid overload however, blade would not remain in window lock and would skip out of window lock every time it was activated.The doctor was able to remove all pathology but visualization was extremely turbulent due to lack of window lock.After case was complete, blade and handpiece were tested outside of patient and window lock could not be maintained.Device will not be returned for evaluation.

Manufacturer Narrative

Device not returned for evaluation.(b)(4).Product evaluation: smith & nephew is unable to provide an analysis of the reported complaint pertaining to the referenced smith & nephew product, as the product was not returned from the facility.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.The complaint is being closed with no conclusion.However, if the product is received in the future the complaint can be reopened and evaluated.No further investigation is required.

• Brand Name: TRUCLEAR INCISOR PLUS BLADE 2.9
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4826953
• MDR Text Key: 5910101
• Report Number: 3003604053-2015-00018
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

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 Expiration Date: 02/01/2016
• Device Catalogue Number: 72202536
• Device Lot Number: B05868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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