SERV REPL, HD COUPLER, 19.5MM

Additional Manufacturer Narrative

VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. IT IS DIFFICULT TO PERFORM AN ACCURATE EVALUATION OF A FAILURE WITHOUT HAVING THE FAILED PRODUCT TO LOOK AT. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION. HOWEVER, IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED. OUR QUALITY DEPARTMENT WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.

Additional Manufacturer Narrative

AN EVALUATION WAS PERFORMED BY SMITH & NEPHEW AND COULD NOT CONFIRM THE CUSTOMER COMPLAINT FOR THE DEVICE NOT HOLDING. A VISUAL INSPECTION WAS PERFORMED AND SHOWED NO DAMAGE TO THE CAMERA COUPLER. THE COUPLER WAS ATTACHED TO THE CAMERA SYSTEM AND DISPLAYED A CLEAR SHARP IMAGE. THIS COUPLER FUNCTIONED AS INTENDED. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED. REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS NOT HOLDING DURING THE CASE AND NO BACK-UP DEVICE WAS AVAILABLE. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE CASE. HOWEVER, NO DELAY, PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

AWAITING RECIEPT OF DEVICE.

Description of Event or Problem

IT WAS REPORTED NOT HOLDING. NO DELAY WAS NOTED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.