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

Catalog Number 72202536

Device Problem Device Slipped (1584)

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

Event Date 08/08/2013

Event Type  malfunction  

Event Description

During a polyp removal procedure the truclear incisor plus blade would not hold when the scope was inserted.When the blade was inserted distention did not hold.No product returning for evaluation.

Manufacturer Narrative

Method: no product were returned for evaluation.The truclear incisor plus blade 2.9 product that was reported to have malfunctioned during a procedure was not returned for evaluation.If the product is received in the future the complaint can be reopened and evaluated.Smith & nephew will continue to monitor for trends of the reported complaint condition for further occurences.Root cause could not be determined with any confidence.(b)(4).

• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4840135
• MDR Text Key: 5910881
• Report Number: 3003604053-2015-00023
• 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: Health Professional
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/10/2015

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: 04/30/2016
• Device Catalogue Number: 72202536
• Device Lot Number: B33531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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