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 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

Failure to achieve or maintain window lock may contribute to loss of distension, which may cause loss of visualization of the operative field, which may lead to serious injury and necessitate medical or surgical intervention to preclude damage to the uterus, bowel or other adjacent body structures.

Event Description

It was reported the truclear handpiece had window lock issues.

• 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: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 7059371
• MDR Text Key: 93221821
• Report Number: 1643264-2017-01778
• 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: 11/27/2017

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: 02/04/2016
• Initial Date FDA Received: 11/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1