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

Catalog Number 72202961

Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408); Improper Device Output (2953)

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

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the arthroscopic lens suddenly became darker during surgery; vision became darker and the lens could not be used any further.A backup device was available.No patient impact reported.There was a short delay of less than 30 minutes.

Manufacturer Narrative

Device investigation narrative: an evaluation was performed by the smith & nephew technical service center in (b)(4).A visual inspection was performed and showed the optical assembly and the focus mechanism performs within working specifications.There is minor exterior damage which consisted of scratches on the negative lens.No manufacturing relate defects were observed.No further investigation is required.(b)(4).

• Brand Name: VIDEOARTHROSCOPE, HD, 4MM X 30 DEG
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5877548
• MDR Text Key: 53003297
• Report Number: 3003604053-2016-00041
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K043395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

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: 72202961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• 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