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

Catalog Number 72202536

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the window lock on the truclear incisor blade would not lock.It is alleged that this caused a minimal delay of approximately 5 minutes and that the device in question was used to successfully complete the procedure.Reportedly, there was no injury to the patient.

• Brand Name: TRUCLEAR INCISOR DEVICE
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5401729
• MDR Text Key: 37228482
• Report Number: 3003604053-2016-00005
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/28/2016

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: 11/01/2018
• Device Catalogue Number: 72202536
• Device Lot Number: E68810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/01/2016
• Date Device Manufactured: 11/25/2015
• 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