MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 70°; ARTHROSCOPE

Catalog Number 72202088

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/11/2018

Event Type  malfunction  

Event Description

It was reported that the scope was foggy.No back up device was available.No delay or patient injury reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for a foggy image.A visual inspection was performed and showed the scope to have distal tip damage and a bent outertube with internal cracked lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.No further investigation is required.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 70°
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7608550
• MDR Text Key: 111849763
• Report Number: 3003604053-2018-00095
• Device Sequence Number: 1
• Product Code: HRX
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

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: 72202088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/17/2018
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1