MENISECTOMY ELECTRODE, BASIC KIT; STD DESIGN

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS MENISCECTOMY ELECTRODE IN A KNEE ARTHROSCOPY, THE TIP OF THE ELECTRODE BROKE AND WAS UNABLE TO BE RETRIEVED. THE UNRETRIEVED TIP WAS DESCRIBED BY THE MEDICAL STAFF AS BEING 1/4 INCH IN LENGTH. THE PROCEDURE WAS COMPLETED AS INTENDED WITH MINIMAL DELAY, AND WITHOUT FURTHER MEDICAL AND SURGICAL INTERVENTION. THE PT WAS DISCHARGE HOME THE SAME DAY.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AN EVALUATION OF THE DEVICE IS UNABLE TO BE PERFORMED BECAUSE THE FACILITY IS RETAINING THE DEVICE. A REVIEW OF PRODUCT HISTORY FOR THE PAST TWO YEARS FOUND NO OTHER REPORTS FOR TIP BREAKAGE UNRETRIEVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER FOUND NO DISCREPANCIES. THIS TYPE OF FAILURE MAY OCCUR WITH HIGH POWER GENERATOR SETTINGS. THE USER FACILITY COULD NOT PROVIDE THE SETTINGS USED DURING THIS EVENT OR INFO REGARDING THE GENERATOR IN USE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE THE FOLLOWING USER INFO: INDICATIONS FOR USE: THESE ELECTRODES ARE USED IN ARTHROSCOPIC PROCEDURES TO CUT AND COAGULATE SOFT TISSUE. CAUTIONS: HIGH POWER GENERATOR SETTINGS MAY RESULT IN DAMAGE TO THE INSULATION, MELTING OF THE ELECTRODE TIP OR INCREASED RISK OF PT BURNS. INSTRUCTIONS FOR USE: SUGGESTED SETTING RANGE IS 30-60 WATTS. PRESS THE "CUT" BUTTON TO CUT, OR THE "COAG" BUTTON TO COAGULATE.