MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP,VAS,2.7X30 DEG,SH,; ARTHROSCOPE

Catalog Number 4131S

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

It was reported that during endoscopic thermal tunnel, device was scratched.There was no back up device available.No delay or patient injuries reported.

Manufacturer Narrative

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

• Brand Name: SERVICE REP,VAS,2.7X30 DEG,SH,
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8785485
• MDR Text Key: 150854893
• Report Number: 3003604053-2019-00076
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K971253
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4131S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1