GROOVED DIRECTOR W/PROBE END &TONGUE TIE

Description of Event or Problem

TIP BROKE OFF IN PATIENT. PROCEDURE WAS IN (B)(6) 2010 AND IT WAS FOUND TODAY, (B)(6) 2010 AFTER PATIENT COMPLAINED OF PAIN THEY WERE EXPERIENCING.

Additional Manufacturer Narrative

AN INVESTIGATION WAS INITIATED INTO THE MATTER OF, "BROKEN TIP" DURING USE. THE EFFECTED INSTRUMENT WAS NOT RECEIVED FOR EVALUATION; THE EFFECTED INSTRUMENT IS CRUCIAL FOR A COMPLETE AND ACCURATE ANALYSIS OF THE CONCERN. A REVIEW OF TREND REPORTS OVER THE LAST 5 YEARS HAS REVEALED NO PREVIOUS INCIDENTS OF ANY NATURE. IF THE SAMPLE IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THE EFFECTED INSTRUMENT WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE REMAINING TIP PORTION OF THE EFFECTED INSTRUMENT WAS AVAILABLE FOR REVIEW BY OUR REPRESENTATIVE IN (B)(4) 2011. DURING THE INVESTIGATION OUR TEAM IDENTIFIED THE FOLLOWING ISSUES: WE WERE UNABLE TO CONFIRM THE BROKEN INSTRUMENT WAS A V. MUELLER PRODUCT. THE BROKEN PIECE OF THE INSTRUMENT REVIEWED HAD NO IDENTIFICATION MARKINGS THAT WOULD ALLOW US TO IDENTIFY THE PRODUCT CODE, LOT CODE, OR MANUFACTURER. DURING THE ON-SITE EVALUATION OF THE REMAINING INSTRUMENTS PROVIDED BY THE HOSPITAL REPRESENTATIVES, IT WAS OBSERVED THAT THERE WERE SAMPLES FROM ANOTHER COMPANY OTHER THAN V. MUELLER. SOME OF THE INSTRUMENTS REVIEWED SHOWED SIGNS OF AN INSTRUMENT THAT WAS MANIPULATED AND STRAIGHTENED SEVERAL TIMES. THIS INSTRUMENT IS NOT MEANT TO BE MANIPULATED. THE PICTURES OBTAINED IN THE INVESTIGATION WERE FORWARDED TO THE MANUFACTURER ALONG WITH A REPRESENTATIVE SAMPLE OF THE PRODUCT CODE. WITHOUT THE PHYSICAL SAMPLE OF THE INVOLVED ITEM TO REVIEW AND THE LIMITED LEVEL OF DETAIL OF THE PICTURES PROVIDED TO THEM, THE MANUFACTURER IS UNABLE TO DETERMINE SEVERAL IMPORTANT ASPECTS NEEDED TO DETERMINE THE ROOT CAUSE OF THE FAILURE, INCLUDING WHETHER THIS IS AN INSTRUMENT THEY MANUFACTURED AND WHEN IT WAS MANUFACTURED. THE ONLY WAY THE MANUFACTURER WAS ABLE TO PRODUCE A SIMILAR DEFECT WAS TO BEND THE ITEM AT THE WELD, WHICH IS CONSIDERED MISUSE OF THE ITEM. THE MANUFACTURER STATED THAT THIS INSTRUMENT WAS NOT MEANT TO BE BENT. A REVIEW OF TREND REPORTS OVER THE LAST 5 YEARS ALONG WITH A COMPLETE EVALUATION OF THE INSTRUMENT HISTORY HAS REVEALED NO PREVIOUS INCIDENTS OF ANY NATURE.