MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 30°; ARTHROSCOPE

Catalog Number 72202087

Device Problem Image Display Error/Artifact (1304)

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

Event Date 09/04/2018

Event Type  malfunction  

Event Description

It was reported that there is a black spot when being attached to the camera.The incident date is tentative.It is a demo unit.No smith & nephew backup device was available to complete the procedure.There was no delay or patient injuries reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the scope has spots.A visual inspection was performed and showed the scope to have distal tip damage, negative lens damage and residue buildup.This damage is caused by contact with another source and improper cleaning.No manufacturing related defects were observed.

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.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 30°
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7995809
• MDR Text Key: 124824379
• Report Number: 3003604053-2018-00166
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010616869
• UDI-Public: 03596010616869
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• 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: 03/13/2019

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: 72202087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 09/30/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 03/12/2019
• Supplement Dates FDA Received: 11/02/2018; 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1