MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG

Model Number 72202961S

Device Problems Crack (1135); Optical Obstruction (3002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the scope's lens were externally cracked and had black dots.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual function found distal tip damage and particulates in the c-mount.There were no cracks.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A function evaluation found a clear image.The particulates are on the c-mount, only visible by the eye not on the camera system.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: VIDEOARTHROSCOPE HD 4MM X 30 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11329989
• MDR Text Key: 233763565
• Report Number: 3003604053-2021-00039
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885554024203
• UDI-Public: 00885554024203
• Combination Product (y/n): N
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202961S
• Device Catalogue Number: 72202961S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1