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

Catalog Number 72202536

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hysteroscopy procedure, the window lock on the device came out twice during the procedure.The procedure was completed with this device.No patient injury or complications were reported.

Manufacturer Narrative

A visual inspection was performed and showed the blade has been used in the field.The investigation results indicated the window lock laser mark was in the correct location.There is evidence that the blade is bent.This is caused by excessive force applied to the outer tube and would cause an issue with the window lock.No manufacturing related defects were observed.After the evaluation, the root cause for the reported issue was determined to be user error.A review of the device history record was performed which confirmed no inconsistencies.

• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5889577
• MDR Text Key: 52616757
• Report Number: 3003604053-2016-00042
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

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: 01/31/2019
• Device Catalogue Number: 72202536
• Device Lot Number: E91985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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