BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM

    MDR report key: 2795176 · Received October 17, 2012

    Report

    Report Number
    9680837-2012-00022
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 17, 2012
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    HIM
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ANALYSIS: TUBE CEV649-5B DIA 5MM 350MM: THE SHEATH HAS PROBABLY BEEN DAMAGED BY SOME SHOCKS AND AN EXCESSIVE ABRASION. HANDLE CEV6385R DIA 5MM STR MONOPOLAR: NO PROBLEM NOTED. THE INSTRUMENT IS CONFORMS TO MANUFACTURING STANDARD. SCISSORS INSERT CEV605-1 350MM DIA 5MM: THE INSTRUMENT HAS PROBABLY REPAIRED BY AN EXTERNAL PROVIDER NOT APPROVED BY MICROFRANCE (ETCHING FROM ANOTHER SOURCE NOTED). EVENT RESULTS: NO FACTORY DEFECTS HAVE BEEN DETECTED ON THE MICROFRANCE INSTRUMENTS RETURNED. THE INVESTIGATION HAS HIGHLIGHTED A REPAIR OUTSIDE OF MEDTRONIC AND A DAMAGED SHEATH. ALTHOUGH WE DO NOT RECOMMEND SUCH PRACTICES, THESE ANOMALIES, FROM OUR POINT OF VIEW, WOULD NOT LIKELY LEAD TO THE REPORTED EVENT. CONSIDERING THE EXPLANATIONS FROM THE SURGEON, IT IS PROBABLE THAT THE BURN IS THE CONSEQUENCE OF THE ELECTRIC ARC FOLLOWING A DAMAGED GLOVE. (QUALITY OF GLOVES USED RECENTLY WAS REPORTED TO BE BAD). THIS IS THE FIRST REPORTED OCCURRENCE OF THIS TYPE OF INCIDENT ON THIS INSTRUMENT IN THE PAST 12 MONTHS. THE INSTRUMENT USED COULD NOT BE IDENTIFIED BUT IS BEING PRESUMED A POTENTIALLY MICROFRANCE (MXI) INSTRUMENT, BUT WITH NO CERTAINTY. DISCUSSION WITH THE SURGEON REVEALED THE SURGEON NOTED A BAD QUALITY OF GLOVES WAS BEING USED. FROM THIS DISCUSSION, THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT IS AN ELECTRIC ARC BEING ALLOWED TO CONTACT THE SURGEON DUE TO WEARING A DAMAGED GLOVE. JAX CONCURS THAT THE MOST LIKELY ROOT CAUSE IS THE WEARING OF POOR GLOVES DURING THE PROCEDURE AND THE INCIDENT IS NOT DUE TO THE INSTRUMENTS USED IN THE PROCEDURE. MXI REPORTS THAT THERE IS NO RISK OF DEATH OR PERMANENT INJURY. NO FURTHER INVESTIGATIONS OR ACTIONS ARE NECESSARY. PRODUCT DESCRIPTION: CAUTERIZATION INSTRUMENTS IS INTENDED FOR USE DURING LAPAROSCOPIC SURGICAL PROCEDURE TO COAGULATE TISSUE OR ARREST BLEEDING USING A HIGH FREQUENCY ELECTRIC CURRENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE, THE SURGEON RECEIVED A BURN TO THUMB DURING COAGULATION. (THE INSTRUMENT HAS NOT BEEN IDENTIFIED - POTENTIALLY THIS MANUFACTURER BUT THE INSTRUMENT COULD NOT BE IDENTIFIED OR VERIFIED). THE SURGEON STATED THERE WAS NOT A SIGNIFICANT INJURY, VERY LOCAL, AND THE BURN SHOULD HEAL WITH NO INTERVENTION. THE SURGEON REPORTED THEY HAD RECEIVED LOW QUALITY OF SURGICAL GLOVES, WHICH HE SUSPECTS COULD BE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE CEV649-5B DIA 5MM 350MM ELECTROCAUTERY, ENDOSCOPIC AND ACCESSORIES HIM XOMED MICROFRANCE MFG CEV649-5B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDLE CEV6385R DIA 5MM STR MONOPOLAR,SCISSORS IN