MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HD VAS 1.9MM X 30 DEG NON-A/C; ARTHROSCOPE

Catalog Number 7208133

Device Problems Image Display Error/Artifact (1304); Loss of Data (2903); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2019

Event Type  malfunction  

Event Description

It was reported that during a wrist arthroscopy, the rod was bent and there was loss of image.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 the rod was bent.A visual inspection was performed and showed the scope to have a bent outer tube, broken weld, and broken lenses.The damage is caused by contact with another source.

• Brand Name: HD VAS 1.9MM X 30 DEG NON-A/C
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8312548
• MDR Text Key: 135684206
• Report Number: 3003604053-2019-00012
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/12/2019
• Patient Sequence Number: 1