MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTL HD FP LCD 24 SONY LMD-2451MD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72203007

Device Problem Insufficient Information (3190)

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

Event Date 11/08/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, when the "on" button was pressed, the screen turned completely green.No back-up device was available.No delay was reported.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A visual inspection of the customer provided image showed that the monitor screen is green while the device is turned on.The device has been in service for over five years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review found no related failures.The complaint was confirmed and the root cause has been associated with electrical component failure.Please note, this issue may be related to a concomitant device.No containment or corrective actions are recommended at this time.

• Brand Name: INTL HD FP LCD 24 SONY LMD-2451MD
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9469159
• MDR Text Key: 170793417
• Report Number: 1643264-2019-00878
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1