SERV REPL, HD COUPLER, 19.5MM
Received Nov 7, 2016 · Event occurred Oct 17, 2016
Report 3003604053-2016-00107 · MDR key 6084162
Device
Generic name
Instrument, Special Lens, For Endoscope
Manufacturer
Smith & Nephew, Inc.Catalog number
72201635S
Lot number
BBB2125
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAD BROKEN PARTS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
AN EVALUATION WAS PERFORMED BY THE SMITH & NEPHEW AND COULD CONFIRM THE CUSTOMER COMPLAINT FOR THE DEVISE HAVING A BROKEN PART. A VISUAL INSPECTION WAS PREFORMED AND SHOWED THE COUPLER HAS BEEN USED IN FIELD. THIS DEVICE WAS SHIPPED TO THE CUSTOMER IN 2011. THE EYEPIECE IS CRACKED EXPOSING THE O-RING. THIS IS CAUSED BY HARD CONTACT TO THE EYEPIECE. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED.