COUPLER, HD, 19.5MM
Received Aug 14, 2019
Report 3003604053-2019-00092 · MDR key 8892629
Device
Generic name
Instrument, Special Lens, For Endoscope
Manufacturer
Smith & Nephew, Inc.Catalog number
72201635
Product problems
- Misfocusing
- Misfocusing
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN EVALUATION WAS PERFORMED BY SMITH AND NEPHEW AND COULD NOT CONFIRM THE CUSTOMER COMPLAINT FOR THE PIECES WON'T STAY TOGETHER AND LOOSE FOCUS. A VISUAL INSPECTION WAS PERFORMED AND SHOWED NO COMPONENTS OF THE COUPLER WERE LOOSE. THE COUPLER IS SCRATCHED , DENTED, AND SEVERELY FADED. FUNCTIONAL INSPECTION WAS PERFORMED AND SHOWED WHEN THE COUPLER WAS ATTACHED TO THE CAMERA SYSTEM IT PROVIDED A CLEAR SHARP IMAGE. THIS DEVICE WAS SHIPPED TO THE CUSTOMER ON 10/08/2010. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO MANUFACTURING RELATED DEFECTED WERE OBSERVED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DEVICE WOULD NOT STAY FOCUS SECURE AND LOSE FOCUS. THERE WAS A DELAY OF MORE THAN 30 MINUTES. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED.