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

Catalog Number 7209807

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the blade skips when locked.

• Brand Name: TRUCLEAR HANDPIECE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7054281
• MDR Text Key: 93092718
• Report Number: 1643264-2017-01760
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/22/2017

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 Catalogue Number: 7209807
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 11/22/2017
• Type of Device Usage: N
• Patient Sequence Number: 1