Description of Event or Problem · 1
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK ENDOSCOPY ACTIVE CORD WITH A VALLEY LAB ELECTROSURGICAL UNIT AND A ENDOSCOPIC ACCESSORY DEVICE. THE PHYSICIAN ADVANCED THE ACCESSORY DEVICE THROUGH THE ENDOSCOPE FOR THE POLYPECTOMY. WHEN THE PHYSICIAN ACTIVATED THE ELECTROSURGICAL UNIT TO APPLY CURRENT THROUGH THE ACTIVE CORD AND ACCESSORY DEVICE, THE USER REPORTED OBSERVING A PUFF OF SMOKE COMING FROM THE ACTIVE CORD NEAR THE END CONNECTED TO THE ACCESSORY DEVICE. THE ACTIVE CORD WAS REPORTED TO BE BROKEN AND WAS REMOVED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION. OUR EVALUATION OF THE RETURNED ACTIVE CORD CONFIRMED THE REPORT OF A BROKEN CORD. UPON VISUAL EXAMINATION OF THE ACCESSORY CONNECTION END, WE CONFIRMED THAT THE INNER WIRE AND OUTER SHEATH HAVE BROKEN. THE ACCESSORY END OF THE ACTIVE CORD HAD SEVERED COMPLETELY AT THE BROKEN AREA. THE APPEARANCE OF THE INNER WIRES AND OUTER SHEATH AT THE BROKEN AREA SUGGEST BURNING HAS ALSO OCCURRED. THE AREA OF THE BREAK SUGGESTS A SEVERE KINK WAS PRESENT, RESULTING IN THIS OBSERVATION. NO OTHER KINKS OR DAMAGED AREAS WERE OBSERVED IN THE ACTIVE CORD. THE ACTIVE CORD WAS REVIEWED WITH ENGINEERING PERSONNEL AND THE FOLLOWING INFORMATION WAS PROVIDED: THE ACTIVE CORD HAS A SINGLE WIRE INSIDE THE INSULATED SHEATH. THE APPEARANCE OF THE DAMAGED AREA SUGGESTS A SEVERE KINK OR BREAK IN THE WIRE OCCURRED NEAR THE ACCESSORY CONNECTION END. IT IS LIKELY THE SEVERE KINK OR BREAK NEAR THE ACCESSORY CONNECTION END CAUSED DAMAGE TO THE INSULATION. ONCE ELECTROSURGICAL CURRENT WAS APPLIED TO THE CORD, THE SEVERELY DAMAGED AREA RESULTED IN SMOKE AND FULL BREAKAGE OF THE CORD. AN OHMMETER WAS USED TO TEST CONTINUITY OF THE ACTIVE CORD. THE ACTIVE CORD IS NOT ABLE TO ALLOW CONTINUOUS CURRENT DUE TO THE BREAKAGE IN THE CORD. AN ACCESSORY DEVICE FROM OUR LABORATORY STOCK WAS CONNECTED TO THE ACTIVE CORD TO ENSURE THE HANDLE OF THE ACCESSORY CONNECTED TO THE ACTIVE CORD PROPERLY. THE CONNECTION WAS VERIFIED TO BE APPROPRIATE AND SECURE. A MANUFACTURING DISCREPANCY OR ANOMALY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OCCURRENCE WAS NOT OBSERVED DURING OUT LABORATORY ANALYSIS. THE POSSIBLE LOT NUMBERS OF THE AFFECTED DEVICES WERE USED TO REVIEW THE DEVICE HISTORY RECORDS. AFTER A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE POSSIBLE LOTS, WE CAN ADVISE THAT NO DISCREPANCIES OR ANOMALIES WERE NOTED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THESE LOTS BECAUSE ALL DEVICES HAD BEEN PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS INFORMATION, THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. CONCLUSIONS: IT IS LIKELY THAT APPLYING ELECTROSURGICAL CURRENT THROUGH A DAMAGED ACTIVE CORD (I.E. SEVERE KINK AND/OR WIRE BREAKAGE) CAUSED THE REPORTED SMOKE AND BREAKAGE OF THE ACTIVE CORD. KINKS OR OTHER DAMAGED AREAS IN THE ACTIVE CORD CAN OCCUR IF EXCESSIVE PRESSURE IS APPLIED DURING USE AND/OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE FOR THE UNIVERSAL ADAPTER CORD INSTRUCT THE USER NOT TO USE THE CORD IF IT HAS BEEN CUT, BURNED OR DAMAGED. THE INSTRUCTIONS FOR USE CAUTION CAUTION THE USER THAT DAMAGED INSULATION MAY CAUSE UNSAFE CURRENTS IN EITHER THE PATIENT OR OPERATOR. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT ANY ELECTROSURGICAL ACCESSORY DEVICE CONSTITUTES A POTENTIAL ELECTRICAL HAZARD TO THE PATIENT AND OPERATOR. THE INSTRUCTIONS FOR USE LIST POSSIBLE ADVERSE EFFECTS WHICH INCLUDE, BUT ARE NOT LIMITED TO FULGURATION AND BURNS. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO, TO A LARGE EXTENT, ON FACTORS UNDER THE CONTROL OF THE OPERATOR. THE INSTRUCTIONS SPECIFY THAT IT IS IMPORTANT THE CAUTIONS LISTED IN THE INSTRUCTIONS FOR THE ACTIVE CORD, AS WELL AS THE INSTRUCTIONS SUPPLIED WITH THE ELECTROSURGICAL UNIT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENHANCE SAFETY AND EFFECTIVENESS. THIS ACTIVE CORD IS A REUSABLE DEVICE. THE LOT NUMBER WAS REQUESTED FROM THE INITIAL REPORTER, BUT WAS UNABLE TO BE PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, WE CAN ADVISE THAT TWO DEVICES HAD BEEN INVOICED TO THIS FACILITY. ONE ACTIVE CORD WAS SHIPPED IN AUGUST 2005 AND THE SECOND WAS SHIPPED IN AUGUST 2007. WE ARE UNABLE TO DETERMINE WHICH ACTIVE CORD IS RELATED TO THIS OCCURRENCE. THE REUSABILITY OF A REUSABLE DEVICE IS DEPENDENT ON THE CARE PROVIDED BY THE USER BEFORE, DURING AND AFTER EACH USE. PRIOR TO DISTRIBUTION, ALL UNIVERSAL ACTIVE CORDS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION INCLUDES VERIFYING THAT THERE ARE NO KINKS OR BENDS IN THE CORD. THE FUNCTIONAL INSPECTION INCLUDES A TEST TO ENSURE ELECTRICAL CONTINUITY FLOW THROUGHOUT THE CORD. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE POSSIBLE LOTS MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO ACTION WARRANTED AT THIS TIME BECAUSE THIS OCCURRENCE MAY BE RELATED TO THE HANDLING OF A REUSABLE PRODUCT. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS CALCULATION, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.