MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE ACLV 2.7 X; ARTHROSCOPE

Catalog Number 7205682S

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/13/2018

Event Type  malfunction  

Event Description

It was reported that during a wrist scope, the surgeon was trying to focus, and it looked really foggy outside of joint.The surgeon could not see anything and it was a foggy red inside the joint.The doctor witched scoped and tried again and had the same result, the image was fine with the scope off the camera head.Ruled out camera head issue.The procedure was completed with a backup device.No patient injury was reported.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for a foggy image.A visual inspection was performed and showed the scope to have residue on the exterior of the negative lens.It is undermined where the residue came from.Further evaluation showed distal tip and fiber damage.This is caused by contact with another source.No manufacturing related defects were observed.

• Brand Name: SVCE REPL ASCOPE ACLV 2.7 X
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7329190
• MDR Text Key: 102199362
• Report Number: 3003604053-2018-00037
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

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: 7205682S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1