MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO VIDEOARTHROSCOPE REV POST HD 4MM X30

Catalog Number 72202963S

Device Problem Insufficient Information (3190)

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

Event Date 06/24/2019

Event Type  malfunction  

Event Description

It was reported that during shoulder scope surgery, the scope had black dots on the end.No backup device was available to complete the procedure.No delay or patient injuries were reported.

Manufacturer Narrative

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

• Brand Name: MTO VIDEOARTHROSCOPE REV POST HD 4MM X30
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8838939
• MDR Text Key: 152618519
• Report Number: 3003604053-2019-00084
• 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: 08/07/2019

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: 72202963S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1