MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS HD AC 4MM X 30 DEG; TABLE, INSTRUMENT, MANUAL, OPHTHALMIC

Catalog Number	72202959
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the "4mm x 30° hd video arthroscope" did not have a clear image.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: further assessment of information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that no harm nor injury was reported and no previous injury or harm has been confirmed to be caused by the device in the past, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: VAS HD AC 4MM X 30 DEG
• Common Device Name: TABLE, INSTRUMENT, MANUAL, OPHTHALMIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10060038
• Report Number: 3003604053-2020-00045
• Device Sequence Number: 3573978
• Product Code: HRK
• UDI-Device Identifier: 00885554018783
• UDI-Public: 885554018783
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: HRX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 72202959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1