MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 30 DEG; ARTHROSCOPE

Catalog Number 72202959

Device Problem Insufficient Information (3190)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy, the device was not working.The procedure was completed with a back up device with no patient injury reported.A delay greater than 30 minutes was reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the device was not working.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a bent outertube and a broken lens.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: VAS, HD, AC, 4MM X 30 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9000694
• MDR Text Key: 183481046
• Report Number: 3003604053-2019-00118
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885554018783
• UDI-Public: 00885554018783
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1