MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPLASCOPE2.7MM X 70; ARTHROSCOPE

Catalog Number 3948S

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

It was reported that the device was bent causing the loss of visualization through the scope.Occurred during procedure.No delay was reported, a back-up device was available.No patient injury.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the device was bent causing the loss of visualization through the scope.A visual inspection was performed and showed the outertube is bent with internal cracked lenses.This is caused by excessive force applied to the outertube.No manufacturing related defects were observed.No further investigation is required.

• Brand Name: SVCE REPLASCOPE2.7MM X 70
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7612317
• MDR Text Key: 111836302
• Report Number: 3003604053-2018-00097
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3948S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization