MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMAGE MANAGEMENT SYSTEM 660HD-E; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Catalog Number UNKNOWN

Device Problem No Display/Image (1183)

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

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during knee arthroscopy- partial meniscectomy surgery, the device loss the live image due to interference caused by the quantum console.This occurred despite the quantum console being plugged into a separate plug point from the camera stack.The procedure was completed successfully with the same device, using only the coag function which didn¿t cause interference.Delay or patient injuries were not reported.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4) (s+n austin).The correct manufacturing site information and registration number is (b)(4) (s+n oklahoma).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• Brand Name: IMAGE MANAGEMENT SYSTEM 660HD-E
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8502505
• MDR Text Key: 141944377
• Report Number: 3006524618-2019-00177
• Device Sequence Number: 1
• Product Code: LMB
• 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,Followup
• Report Date: 02/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1