MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LT. GUIDE,GEMINI,5MM X 12FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 7205177

Device Problem Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a patient was burned on the abdomen (second degree) because of an overheating of the cable.It is unknown if a back-up device was available and if there was delay in the procedure.

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.

• Brand Name: LT. GUIDE,GEMINI,5MM X 12FT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8564732
• MDR Text Key: 143550214
• Report Number: 3003604053-2019-00053
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010251107
• UDI-Public: 03596010251107
• Combination Product (y/n): N
• PMA/PMN Number: D173485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7205177
• Device Lot Number: 137011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other