MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHORSCOPE, HD, 4MM X 70 DEG; ARTHROSCOPE

Catalog Number	72202962S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the videoarthorscope hd 4mm x 70 deg was all black and was unable to see through it.This occurred during the surgery.It is unknown if a backup device was available to complete the procedure.There were no delays or patient injuries reported.
Additional Manufacturer Narrative
Device investigation narrative - an evaluation was performed by the supplier and could confirm the customer complaint that they were unable to see through the scope.A visual inspection was performed and showed the scope to have distal tip and fiber damage.No manufacturing related defects were observed.No further investigation is required.

• Brand Name: VIDEOARTHORSCOPE, HD, 4MM X 70 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 6483462
• Report Number: 3003604053-2017-00046
• Device Sequence Number: 16165954
• Product Code: HRX
• UDI-Device Identifier: 00885554024210
• UDI-Public: (01)00885554024210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72202962S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1