BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGOSCOPE MCL51 150MM MED LEGENT [MXI/XOM]

    MDR report key: 3342986 · Received September 11, 2013

    Report

    Report Number
    9680837-2013-00469
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    July 23, 2013
    Report Date
    September 23, 2013
    Manufacturer
    MEDTRONIC MICROFRANCE, INC.
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD ¿ NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(6) 2013. ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE AT THE USER FACILITY: THE PROCEDURE LASTED A TOTAL OF 11 MINUTES AND AT THE END OF THE PROCEDURE THEY NOTICED THAT THERE WAS A BURN ON THE PATIENT'S LIP BETWEEN THE TIP OF THE NOSE AND THE LIP (2CMX2CM); THE SKIN WAS WHITE AND DID NOT BLISTER SO THEY BELIEVE IT WAS A 3RD DEGREE BURN. THE BURN WAS TREATED WITH BACITRACIN. THE PATIENT RETURNED APPROXIMATELY TWO WEEKS POST-OP FOR FOLLOW UP WITH A SCAB AT THE BURN SITE. THE PATIENT WAS GIVEN SILVADENE CREAM AND ORDERED TO APPLY 3X'S DAILY. THEY ARE NOT SURE IF THERE WILL BE A SCAR AT THIS POINT. THE USER FACILITY ALSO REPORTED THAT THE LIGHT SOURCE DEVICE USED WAS A NON-MEDTRONIC DEVICE AND UPON TESTING THIS DEVICE IT HEATED UP QUICKLY AND GOT VERY HOT AND CAUSED THE LARYNGOSCOPE COMPONENT TO HEAT UP QUICKLY AS WELL. THE DEVICE WAS RETURNED AND PRODUCT ANALYSIS IS CURRENTLY UNDERWAY. METHOD: ACTUAL DEVICE EVALUATED. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS. 11 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: MCL53 LEGENT LIGHT FIBER (THIS COMPONENT ATTACHES TO MCL51) LOT/SERIAL NUMBERS ARE UNKNOWN; MFR DATE UNKNOWN. THE INSTRUMENTS WERE EVALUATED BY THE QUALITY ENGINEERING TEAM. VISUAL AND MICROSCOPIC INSPECTION OF THE LIGHT FIBER (MCL53) SHOWED NO INDICATION OF PHYSICAL DAMAGE. MECHANICAL TESTING WAS CONDUCTED USING A GENERATOR AND A LIGHT FIBER CABLE. THE LIGHT FIBER (MCL53) MET ALL PRODUCT PERFORMANCE AND MANUFACTURING SPECIFICATIONS. NO MALFUNCTIONS OR ABNORMAL HEATING WERE OBSERVED. THERE WAS NO MECHANICAL FAULT FOUND WITH THE LIGHT FIBER (MCL53), AND THERE WAS NO OVERHEATING OBSERVED. CONCLUSION: BASED ON THE AVAILABLE INFORMATION AND THE PRODUCT ANALYSIS, THE ROOT CAUSE IS ¿CAUSED BY ANOTHER DEVICE¿ LIKELY RELATED TO THE LIGHT SOURCE EQUIPMENT AND/OR LIGHT FIBER CABLE, AND ¿USER ERROR¿ DUE TO IMPROPER PLACEMENT OR TECHNIQUE USED. THE USER FACILITY TESTING RESULTS INDICATE THE LIGHT SOURCE EQUIPMENT USED WAS A BFW MAXENON XI300 (LOT/SERIAL NUMBERS UNKNOWN BY FACILITY). THE USER FACILITY TECHNICIAN TESTED THE LIGHT SOURCE, FIBER OPTIC CABLE, AND THE MCL53 LEGENT (LIGHT FIBER FOR MCL51) TOGETHER AND FOUND THAT UPON POWERING THE MAXENON XI300 LIGHT SOURCE BOX, IT HEATED UP VERY QUICKLY AND THE FIBEROPTIC CABLE HEATED UP QUICKLY, AS WELL. THE USER FACILITY TECHNICIAN BELIEVES THAT DURING PLACEMENT OF THE LARYNGESCOPE, THEY POSITIONED IT IN A MANNER THAT ALLOWED THE LEGENT LIGHT FIBER ATTACHMENT (MCL53) TO COME IN CONTACT WITH SKIN TISSUE. AS A RESULT OF THE TESTING AND ANALYSIS BY THE USER FACILITY, THE TECHNICIAN BELIEVES THE MAXENON XI300 WAS THE SOURCE OF THE EXCESSIVE HEAT THAT LED TO THE HOT ACCESSORY DEVICES/COMPONENTS, AND SUBSEQUENT BURN INJURY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A 2X2CM BURN ON HIS LIP FROM THE LARYNGOSCOPE (LIGHT-SOURCE) DURING LARYNGEAL SURGERY. THE BURN WAS DISCOVERED POSTOP. FURTHER INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE AT THE USER FACILITY: THE PROCEDURE LASTED A TOTAL OF 11 MINUTES AND AT THE END OF THE PROCEDURE THEY NOTICED THAT THERE WAS A BURN ON THE PATIENT'S LIP BETWEEN THE TIP OF THE NOSE AND THE LIP (2CMX2CM); THE SKIN WAS WHITE AND DID NOT BLISTER SO THEY BELIEVE IT WAS A 3RD DEGREE BURN. THE BURN WAS TREATED WITH BACITRACIN. THE PATIENT RETURNED APPROXIMATELY TWO WEEKS POST-OP FOR FOLLOW UP WITH A SCAB AT THE BURN SITE. THE PATIENT WAS GIVEN SILVADENE CREAM AND ORDERED TO APPLY 3X'S DAILY. THEY ARE NOT SURE IF THERE WILL BE A SCAR AT THIS POINT. THE USER FACILITY ALSO REPORTED THAT THE LIGHT SOURCE DEVICE USED WAS A NON-MEDTRONIC DEVICE AND UPON TESTING THIS DEVICE IT HEATED UP QUICKLY AND GOT VERY HOT AND CAUSED THE LARYNGOSCOPE COMPONENT TO HEAT UP QUICKLY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456099 LARYNGOSCOPE MCL51 150MM MED LEGENT [MXI/XOM] INSTRUMENT, ENT MANUAL SURGICAL LRC MEDTRONIC MICROFRANCE, INC. MCL51 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other