Description of Event or Problem · 1
MFR'S RESPONSE RECEIVED ON 7/3/97: THE BROKEN BANDS ASSOCIATED WITH THE INCIDENT WERE NOT RETURNED. A SAMPLE OF THE RETURNED BANDS WAS TESTED FOLLOWING THE TEST METHODS USED DURING ROUTINE PRODUCTION. TEN (10) BANDS WERE DILATION TESTED AND TEN (10) BANDS WERE PRESSURE TESTED. THE BANDS THAT WERE DILATION TESTED PASSED THIS TEST IN THAT NONE OF THEM SPLIT OR TORE. ONE OF THE BANDS THAT WAS PRESSURE TESTED FAILED THE PRESSURE TEST. IT SHOULD BE NOTED THAT DURING ROUTINE QUALITY CONTROL TESTING OF BANDS, FOR EVERY SAMPLE OF THIRTY-TWO BANDS TESTED FROM EACH COIL, TWO BANDS ARE ALLOWED TO FAIL THE PRESSURE TEST AND STILL HAVE THE COIL MEET SPECIFICATION. IN ADDITION TO MATERIAL CHARACTERISTICS THAT MAY RESULT IN BAND BREAKAGE, THERE ARE SEVERAL CAUSES OF BAND SPLITTING WHICH HAVE BEEN IDENTIFIED IN THE PAST THAT ARE RELATED TO THE EQUIPMENT UTILIZED IN THE LOADING OF THE BAND ONTO THE APPLICATOR. THESE INCLUDE USING A DEFECTIVE GUIDE, POSSIBLY ONE THAT HAS SHARP EDGES OR A WEAK O-RING, AN APPLICATOR THAT HAS BURRS ON THE DISTAL END OF THE INNER OR OUTER TUBES, OR AN APPLICATOR THAT HAS A WEAK SPRING WHICH MAY MAKE LOADING THE BANDS DIFFICULT. NONE OF THE EQUIPMENT UTILIZED IN THIS EVENT WAS RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN REGARDING THE CAUSE OF THE BAND BREAKAGE EXPERIENCED IN THIS INCIDENT. A REVIEW OF THE COMPLAINT FILES FROM 1988 TO THE PRESENT SHOWS THAT THIS IS THE FIRST INSTANCE IN WHICH THE BREAKING OF A FALOPE-RING BAND LED TO ANY PT COMPLICATION SUCH AS DESCRIBED IN THE REFERENCED MEDWATCH REPORT. NO CHANGES TO THE DEVICE OR STERILIZATION METHOD HAVE BEEN MADE THAT MAY BE RELATED TO THE EVENT.