VAS HD AC 4MM X 30 DEG
Received May 14, 2020 · Event occurred Mar 25, 2020
Report 3003604053-2020-00045 · MDR key 10060038
Device
Generic name
Table, Instrument, Manual, Ophthalmic
Manufacturer
Smith & Nephew, Inc.Catalog number
72202959
Product problems
- Optical Problem
- Optical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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.