MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS, HD, AC, 4MM X 70 DEG; ARTHROSCOPE

Catalog Number 72202958

Device Problem No Display/Image (1183)

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

Event Date 08/07/2019

Event Type  malfunction  

Event Description

It was reported that during a hip arthroscopy there was a black smudge in the scope, causing a complete loss of visualization.The procedure was completed with a backup device with no delay or patient injury reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for there was a smudge in the scope.A visual inspection was performed and showed the scope to have distal tip damage.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: VAS, HD, AC, 4MM X 70 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8952920
• MDR Text Key: 156472936
• Report Number: 3003604053-2019-00107
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 72202958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/31/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1