MENISCECTOMY ELECTRODE, 90 DEGREE TIP

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THE MENISCECTOMY ELECTRODE, 90 DEGREE TIP IN A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2014, THE TIP BROKE OFF IN THE SURGICAL SITE. FOLLOW-UP WITH THE USER FACILITY INDICATED THAT WHEN THE SURGEON WAS ABOUT TO ACTIVATE THE DEVICE, ALLEGEDLY FOR THE FIRST TIME IN THE JOINT SPACE, THE SURGEON NOTICED THAT THE TIP WAS NO LONGER ON THE ELECTRODE. FLUOROSCOPY WAS IMMEDIATELY USED AND THIS CONFIRMED THE BROKEN ELECTRODE TIP WAS IN THE JOINT SPACE/SOFT TISSUE. AN ADDITIONAL INCISION WAS MADE TO REMOVE THE TIP WITH A SUCTION SHAVER BLADE AND X-RAY DID CONFIRM THE TIP HAD BEEN REMOVED. A BACK-UP MENISCECTOMY ELECTRODE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. AS REPORTED, OTHER THAN A 20 MINUTE DELAY AND MINOR SURGICAL INTERVENTION TO REMOVE THE BROKEN TIP, THERE WAS NO SERIOUS INJURY OCCURRED AND THE (B)(6) YEARS OLD, FEMALE PATIENT WAS DISCHARGED AS PER ROUTINE PROCEDURE.

Additional Manufacturer Narrative

CONMED RECEIVED A "USED" AND DAMAGED MENISCECTOMY ELECTRODE ON (B)(4) 2014 FOR EVALUATION. VISUAL INSPECTION FOUND THE TIP WAS BROKEN OFF AND THE COATING ON THE SHAFT, NEAR THE TIP WAS TORN. THE BROKEN PORTION WAS NOT RETURNED. FURTHER EXAMINATION BY THE QUALITY ENGINEER AND R&D ENGINEER FOUND EVIDENCE OF PARTIALLY MELTED SHRINK WRAP, CHARRED TIP, AND TORN INSULATION, WHICH INDICATED THAT THE DEVICE HAD BEEN ACTIVATED AND AN INDICATION THAT IT WAS BEING USED WHEN THE REPORTED PROBLEM OCCURRED. THE EXACT CAUSE OF THIS REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. HOWEVER, BASED ON THE TORN/DAMAGE CONDITION OF THE RETURNED DEVICE, IT IS THEREFORE BELIEVED THAT THE MOST LIKELY CAUSE OF THE REPORTED TIP BREAKAGE IS USER RELATED. THIS DEVICE WAS MANUFACTURED ON 21-MAY-2014. OF THE LOT CONTAINING (B)(4) UNITS((B)(4)), AND THERE ARE NO OTHER COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A REVIEW OF THE DHR SHOWED THERE WERE NO ABNORMALITIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM. ADDITIONALLY, A REVIEW OF THE DEVICE COMPLAINT HISTORY SHOWED THERE HAVE BEEN NO OTHER ADVERSE EVENTS FOR THIS ITEM NUMBER. THIS IS AN ISOLATED INCIDENT. TO REDUCE THE RISK OF INJURY TO THE PATIENT, THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING CAUTIONS: -IF ANY VISUAL DEFECTS ARE NOTICED IN THE INSULATION, OR THE CERAMIC/INSULATION IS DAMAGED IN ANY WAY, STOP USING THE DEVICE IMMEDIATELY AND REPLACE THE DEVICE. -USE CARE WHEN INSERTING INTO AND WITHDRAWING THE ELECTRODE FROM A CANNULA TO AVOID THE POSSIBILITY OF DAMAGE TO THE DEVICES AND/OR INJURY TO THE PATIENT. -HIGH POWER GENERATOR SETTINGS AND/OR PROLONGED USE MAY RESULT IN DAMAGE TO THE INSULATION AND/OR MELTING OF THE ELECTRODE TIP. THE ELECTRODE TIP MUST BE COMPLETELY SURROUNDED BY CONDUCTIVE FLUID WHEN ACTIVATED IN ORDER TO AVOID DAMAGE TO THE INSULATION. -DO NOT INSERT, WITHDRAW OR TOUCH THE ACTIVE ELECTRODE WHEN POWER IS BEING APPLIED. THIS MAY RESULT IN DEVICE DAMAGE. -DO NOT BEND ELECTRODE SHAFT, AS INSULATION MAY BE DAMAGED. -ELECTRODES MUST BE USED IN CONDUCTIVE FLUID MEDIUM TO AVOID INSULATION DAMAGE.