MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPE ACLV 2.7X30D SHORT

Catalog Number 7205682

Device Problem No Display/Image (1183)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

It was reported that during an ankle arthroscopy the scope was bent, and no light was getting through the camera because of this there was a complete loss of visualization during the procedure.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

H10: h2, h3, h6.An evaluation was performed by the supplier and could confirm the customer complaint for the scope was bent.A visual inspection was performed and showed the scope to have a bent outertube, a broken weld and broken lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: ARTHROSCOPE ACLV 2.7X30D SHORT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8933586
• MDR Text Key: 155801938
• Report Number: 3003604053-2019-00101
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010380432
• UDI-Public: 03596010380432
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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: 7205682
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1