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 12/10/2018

Event Type  malfunction  

Event Description

It was reported that the device was cloudy.No back up device was available.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the device is cloudy.A visual inspection was performed and showed the scope to have severe distal tip damage and internal cracked lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8155687
• MDR Text Key: 130318888
• Report Number: 3003604053-2018-00194
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010616869
• UDI-Public: 03596010616869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1