HF-RESECTION ELECTRODE PLASMALOOP ¿ MEDIUM, 30°

Additional Manufacturer Narrative

THE DEVICE LOT 1100164059 WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION OF THE REPORTED "MULTIPLE LOOP TIPS BENT HORRIBLY, SO THEY COULD NOT BE USED AT ALL; TWO LOOP TIPS BROKE OFF". THE DEVICE WAS NOT RECEIVED IN THE ORIGINAL PACKAGE. A VISUAL INSPECTION WAS PERFORMED ON THE DEVICE AND NOTED THAT THE LOOP WIRE AT THE DISTAL END OF THE DEVICE WAS BADLY BENT AND THE TIPS AT THE END OF THE INSULATION POSTS APPEARED TO HAVE BEEN MELTED. THERE WAS CHARRING, AND DAMAGE TO THE BLUE AND YELLOW INSULATIONS POSTS, WHICH ALSO INCLUDES DAMAGE LEADING UP TO THE INSULATION AT THE DISTAL END. THE STABILIZING TUBE SHOWS NO SIGNS OF DAMAGE. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE CUTTING LOOP. AT THIS TIME, A DETERMINATION CANNOT BE MADE IN REGARDS TO A LIKELY CAUSE OF THE REPORTED ISSUE. THIS DEVICE WILL BE FORWARDED TO THE OEM (OSTE) FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

THE OEM (OSTE) CONDUCTED A DHR-REVIEW FOR THE CONCERNED DEVICE. THE DEVICE MANUFACTURER DATE IS JANUARY 30, 2019. MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MOST RECENTLY SOLD ON (B)(6) 2019. THE RESULT OF THE OEM'S INVESTIGATION WAS CONSISTENT WITH THE CUSTOMER'S DESCRIPTION OF FAILURE. AFTER INSPECTING THE ITEM, WE CAN CONFIRM THAT THE PLASMALOOP WIRE AT THE DISTAL END OF THE HF-RESECTION ELECTRODE IS BROKEN AND BOTH ENDS HAVE MELTED INTO BALL SHAPES. THE FORK INSULATION SHOWS SEVERE THERMAL DAMAGE. FURTHERMORE, HEAVILY MELTED MATERIAL ON THE FORK INDICATES THAT THE ELECTRODE HAS COME INTO CONTACT (UNINTENDED) WITH OTHER METAL PARTS, E.G. TELESCOPE, WHILE THE HIGH-FREQUENCY OUTPUT WAS ACTIVATED. THE PRESENT CONDITION CLEARLY INDICATES A HANDLING RELATED ISSUE. WITH REFERENCE TO THE RELATED COMPLAINTS, A COMPREHENSIBLE OVERVIEW OF A RECURRING FAILURE / DAMAGE PATTERN BECOMES EVIDENT. THIS IS IDENTIFIED AS FOLLOWS: DEFORMATION OF THE LOOP AND THE FORK DUE TO MECHANICAL OVERLOAD. UNINTENDED CONTACT BETWEEN THE ELECTRODE AND THE TELESCOPE. ELECTRICAL CURRENT FLOW BETWEEN THE TELESCOPE AND THE FORK. MELTING OF THE LOOP TO A BALL. BREAKAGE OF THE LOOP. LOOP BURN DOWN UP TO THE FORK INSULATION. THERMAL OVERLOAD OF THE INSULATION TUBES. AS REPORTED BY THE CUSTOMER, TWO LOOP TIPS BROKE OFF INSIDE THE PATIENT. THE FRAGMENTS OF THE LOOP WERE RETRIEVED FROM THE PATIENT. HOWEVER, THESE FRAGMENTS WERE NOT MADE AVAILABLE FOR INVESTIGATION NOR THE PICTURES HAVE BEEN PROVIDED. IT IS THEREFORE UNKNOWN AT WHICH POSITON OF THE LOOP THE WIRE HAS BROKEN OFF. BASED ON THE ABOVE ANALYSIS, THE CAUSE FOR THE DAMAGED DEVICE WAS DETERMINED TO BE FROM EXCESSIVE FORCE, (UNINTENDED) CONTACT WITH OTHER SURGICAL INSTRUMENTS. THEREFORE, THIS EVENT IS ATTRIBUTED TO IMPROPER HANDLING, USER ERROR. SINCE THIS FAILURE MODE IS ATTRIBUTED TO IMPROPER HANDLING AND THIS IS A LOW OCCURRENCE RATE ISSUE WITH NO INCREASED/POTENTIAL RISK FOR THE PATIENT OR THE USER, NO COUNTERMEASURES ARE TAKEN BY THE OEM.

Additional Manufacturer Narrative

THE REFERENCED DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE OEM (OSTE); AS A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

DURING A HYSTEROSCOPIC MYOMECTOMY PROCEDURE, THE PHYSICIAN AT THE USER FACILITY NOTED THE RESECTION LOOP AT THE DISTAL END OF THE HF-RESECTION ELECTRODE "BENT UP, BENT DOWN, AT ONE POINT SEEMED TO COMBUST AND FLASH WAS SEEN". WHEN THE HF-RESECTION ELECTRODE WAS RETRACTED THE LOOP WAS REPORTEDLY SEPARATED AND THE TWO INSULATED SHAFTS AT THE DISTAL END WERE STUCK TOGETHER. THE LOOP AT THE DISTAL END CAME OFF THE END OF TWO ELECTRODES. THE LOOP WAS RETRIEVED FROM THE PATIENT. THE RESECTION OF A SEVEN CENTIMETER SUBMUCUSAL FIBROID WAS COMPLETED USING A 6TH ELECTRODE. THIS REPORT IS FOR ELECTRODE 5 OF 5.