BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABC PROBE DISPOSABLE LAPAROSCOPIC 5MM

    MDR report key: 3981897 · Received August 5, 2014

    Report

    Report Number
    3007305485-2014-00077
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K925903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE RESPONSE TO THE REQUEST FOR INFORMATION LETTER DATED 29 OCTOBER 2014. THE FOLLOWING INFORMATION WAS REQUESTED: PLEASE PROVIDE THE RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING UNDERLYING CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT. PLEASE INCLUDE: AN EXPLANATION FOR THE REASON FOR THIS OCCURRENCE BASED ON YOUR FOLLOW-UP WITH THE REPORTING FACILITY OR INDIVIDUAL. RESPONSE: FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE TIP BROKE OFF WHEN THE SURGEON ACTIVATED THE DEVICE. IT WAS ALSO REPORTED THAT DUE TO THE PATIENT BEING ON ANTICOAGULANT MEDICATION, THE LIVER STARTED BLEEDING IMMEDIATELY. TO CONTROL THE BLEEDING, THE SURGEON UTILIZED ARISTA, AN ABSORBABLE HEMOSTATIC POWER AND IN MINUTES THE BLEEDING WAS UNDER CONTROL RESULTING IN MINIMAL BLOOD LOSS. THE BROKEN TIP WAS RETRIEVED, ANOTHER ABC PROBE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS OR SERIOUS INJURY TO THE PATIENT. A COMPLETE DESCRIPTION OF INVESTIGATION AND ANALYSIS METHODOLOGY(IES) USED, RESPONSE: ONE (1) USED DEVICE AND TWO (2) UNUSED ABC PROBES WERE RETURNED TO CONMED COMPLAINT CENTER FOR INVESTIGATION. THE PROBE OF THE USED PRODUCT WAS DETACHED FROM THE DEVICE PRIOR TO RECEIVING. NO BREAK OR DAMAGE WAS OBSERVED ON THE PROBE OR THE TIP AREA. THE OTHER TWO (2) UNUSED DEVICES WERE CONNECTED TO THE SYSTEM 7500 ESU TO CHECK FOR THE FUNCTIONALITY. NO FUNCTIONAL DISCREPANCIES WERE OBSERVED WITH THE UNUSED PRODUCTS. (B)(4). AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED, RESPONSE: IN THIS CASE, A SPECIFIC FAILURE MODE IS UNDETERMINED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) INDICATES, "BEFORE USE, INSPECT THE CORD INSULATION AND HANDPIECE INTEGRITY AND CONDITION. IF DAMAGED, CHIPPED, CUT OR NICKED, DO NOT USE HANDPIECE/PROBE. ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. RESPONSE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT/SERIAL NUMBER DID NOT INDICATE ANY ABNORMALITIES. ADDITIONALLY, THE TWO (2) UNUSED RETURNED DEVICES MET FUNCTIONAL TESTING WITH NO NOTED DISCREPANCIES. AT THIS TIME, THERE IS NO REASON TO BELIEVE THAT ANYTHING ASSOCIATED WITH OUR MANUFACTURING PROCESS CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. PLEASE PROVIDE A COMPLETE LIST OF MEDICAL DEVICE REPORTS (MDRS) THAT YOU HAVE DETERMINED ARE RELATED TO THIS SAME PROBLEM/ISSUE. PLEASE IDENTIFY HOW MANY COMPLAINTS (I.E. FROM ALL SOURCES, INCLUDING BUT NOT LIMITED TO FIELD SERVICE RECORDS, REPAIR HISTORY RECORDS, ETC.) THAT YOUR FIRM HAS RECEIVED IN THE PAST 2 YEARS THAT ARE RELATED TO THIS SAME REPORTED DEVICE PROBLEM. RESPONSE: A TWO YEAR REVIEW OF COMPLAINT HISTORY SHOWS ONLY THIS ONE (1) MEDICAL DEVICE REPORTS (MDRS), FOR THE ABC PROBE FAMILY FOR 1104: DETACHMENT OF COMPONENT. WHAT ACTIONS HAS YOUR FIRM TAKEN TO ADDRESS THIS PROBLEM? RESPONSE: THE PROCESS ANALYSIS DETERMINED THAT NO CORRECTIVE/PREVENTIVE ACTION WAS REQUIRED AT THIS TIME. HOWEVER, THE MANUFACTURING TEAM WAS NOTIFIED OF THIS ISOLATED INCIDENT. A VERIFICATION STEP WAS ADDED TO THE MANUFACTURING PROCESS AND THE OPERATORS WERE TRAINED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CONMED RECEIVED ONE "USED" ARGON BEAM COAGULATOR (ABC) PROBE, DISPOSABLE AND TWO (2) "UNOPENED" UNITS FROM THE SAME LOT NUMBER FOR EVALUATION ON 15-JUL-2014. VISUAL INSPECTION OF THE RETURNED "USED" DEVICE FOUND THE UNIT WAS RECEIVED WITH THE PROBE TIP DETACHED FROM THE MOLDED PLASTIC NOZZLE. FURTHER INSPECTION FOUND NO BREAKAGE OR DAMAGE ON THE PROBE OR THE TIP AREA. THE ROOT CAUSE OF THIS REPORTED "PROBE DETACHMENT" WAS UNABLE TO BE DETERMINED AT THIS TIME. THE TWO RETURNED "UNOPENED" UNITS WERE ALSO EVALUATED AND VISUAL INSPECTION FOUND NO PHYSICAL DAMAGES/DEFECTS. THE TWO UNITS WERE TESTED WITH A TEST SYSTEM AND FOUND BOTH UNITS PERFORMED AS INTENDED WITH NO FUNCTIONAL DISCREPANCIES OR PROBLEMS NOTED. THIS DEVICE WAS MANUFACTURED ON 24-AUG-2010. OF LOT CONTAINING 100 UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED. A REVIEW OF THE DHR FOUND THERE WERE NO ISSUES OR ANY ABNORMALITIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. IN ADDITION, A 2-YEAR REVIEW OF THE COMPLAINT HISTORY FOR THIS DEVICE FAMILY SHOWED ONLY ONE (1) OTHER SIMILAR REPORT RECEIVED. (B)(4). THE LAPAROSCOPIC ARGON BEAM COAGULATION (ABC) EXTENDED PROBE IS A SINGLE PATIENT USE PRODUCT, PROVIDED STERILE. THIS ARGON GAS ENHANCED MONOPOLAR ELECTROSURGICAL DEVICE IS INTENDED TO BE USED THROUGH A LAPAROSCOPIC TROCAR SLEEVE. USE THE LAPAROSCOPIC ABC EXTENDED PROBE ONLY IN SITUATIONS WHERE YOU WOULD NORMALLY USE MONOPOLAR ENERGY. TO REDUCE THE RISK OF PATIENT INJURY, THE INSTRUCTION FOR USE (IFU) OF THIS DEVICE PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: FILE ATTACHMENTS USE OF THE HANDPIECE WITHOUT GAS FLOW MAY CAUSE SEVERE TIP DAMAGE. MAKE CERTAIN THE ABC CONNECTOR IS FULLY SEATED INTO THE GAS SUPPLY RECEPTACLE AND MAKE SURE THE GAS SUPPLY HOSE DOES NOT BECOME KINKED OR CRIMPED. (ALWAYS TEST FOR GAS FLOW PRIOR TO SURGICAL USE BY ACTIVATING THE HANDPIECE AND DIRECTING THE ACTIVE TIP TOWARD POOLED FLUID. APPROPRIATE GAS FLOW WILL RESULT IN FLUID DISPERSION PRIOR TO ESTABLISHMENT OF ARGON BEAM). CARE SHOULD BE TAKEN DURING SURGERY TO PREVENT INADVERTENT CONTACT OF THE HANDPIECE/PROBE TIP WITH TISSUE. BEFORE USE, INSPECT THE CORD INSULATION AND HANDPIECE INTEGRITY AND CONDITION. IF DAMAGED CHIPPED, CUT, OR NICKED, DO NOT USE THE HANDPIECE/PROBE. DO NOT IMMERSE, OR POUR FLUIDS OVER THE HANDPIECE. DO NOT TOUCH THE NOZZLE DIRECTLY TO TISSUE OR OTHERWISE BURY THE NOZZLE TIP IN TISSUE OR FLUIDS WHICH OBSCURE VISUALIZATION OF THE HANDPIECE/PROBE TIP. ARGON BEAM COAGULATION SHOULD BE USED ONLY BY THE SURGEONS EXPERIENCED IN, AND AWARE OF, ARGON BEAM TECHNIQUES AND SAFETY. SINGLE PATIENT USE. DO NOT RE-STERILIZE! THE ABILITY TO EFFECTIVELY CLEAN AND RE-STERILIZE THIS DEVICE HAS NOT BEEN ESTABLISHED AND SUBSEQUENT RE-USE MAY ADVERSELY AFFECT THE PERFORMANCE, SAFETY AND/OR STERILITY OF THE DEVICE. IMPROPER OPERATION OF THIS DEVICE MAY COMPROMISE DEVISE SAFETY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE ARGON BEAM COAGULATOR (ABC) PROBE, DISPOSABLE IN A LAPAROSCOPIC CHOLECYSTECTOMY IN A (B)(6), FEMALE PATIENT, THE NEEDLE TIP WAS BROKEN OFF AND FELL INTO THE PATIENT'S LIVER, PIERCING IT. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE TIP BROKE OFF WHEN THE SURGEON ACTIVATED THE DEVICE. IT WAS ALSO REPORTED THAT DUE TO THE PATIENT BEING ON ANTICOAGULANT MEDICATION, THE LIVER STARTED BLEEDING IMMEDIATELY. TO CONTROL THE BLEEDING, THE SURGEON UTILIZED ARISTA, AN ABSORBABLE HEMOSTATIC POWER AND IN MINUTES THE BLEEDING WAS UNDER CONTROL RESULTING IN MINIMAL BLOOD LOSS. THE BROKEN TIP WAS RETRIEVED, ANOTHER ABC PROBE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS OR SERIOUS INJURY TO THE PATIENT. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Description of Event or Problem · 1

    THIS IS A REQUEST FOR INFORMAITON FOR REPORT NUMBER MW5038786.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458207 ABC PROBE DISPOSABLE LAPAROSCOPIC 5MM ABC PROBE GEI CONMED CORPORATION 1008243

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention