MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEMINI LIGHT CABLE,4MM X 8 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 2985

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/22/2011

Event Type  Injury  

Event Description

It was reported that a paediatric patient was allegedly burned during a knee arthroscopy.The burn required subsequent skin grafting.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.

• Brand Name: GEMINI LIGHT CABLE,4MM X 8 FT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6477191
• MDR Text Key: 72281304
• Report Number: 3003604053-2017-00045
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K14919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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