BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 12204345 · Received July 21, 2021

    Report

    Report Number
    1717344-2021-01008
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 29, 2021
    Report Date
    October 15, 2021
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521750913
    PMA / PMN Number
    K182772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6 H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE RETURNED DEVICE HAVE BEEN SUBJECTED TO IMPROPER CLEANING. IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE AND THE DEVICE DISCHARGED A VISIBLE SPARK. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: WARNING, TISSUE BUILDUP (ESCHAR) ON THE TIP OF AN ACTIVE ELECTRODE POSES A FIRE HAZARD, ESPECIALLY IN OXYGEN-ENRICHED ENVIRONMENTS. ESCHAR PLUS HIGH OXYGEN MAY CREATE EMBERS. KEEP THE ELECTRODE CLEAN AND FREE OF ALL DEBRIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY AND PELVIC LYMPH NODE DISS, THE DEVICE HAD SPARK COMING FROM THE END OF THE PENCIL WHERE THERE WAS ESCHAR BUILD-UP. THE SURGICAL RESIDENT HAD ACTIVATED THE PENCIL TO CAUTERIZE TISSUE AND WHEN STOPPED PRESSING THE BUTTON AND BRINGING THE PENCIL OUT OF THE PELVIS, A FLAME SPARK WAS WITNESSED FROM THE PENCIL FOR A FEW SECONDS. THERE WAS A SMALL AMOUNT OF MATERIAL DEBRIS ON THE TIP OF THE PENCIL BUT THE PENCIL WAS NOT BEING ACTIVATED WHEN THE FLAME WAS NOTED. REMOVED THE PENCIL FROM THE FIELDS. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE HAD SPARK COMING FROM THE END OF THE PENCIL WHERE THERE WAS ESCHAR BUILD-UP. THE SURGICAL RESIDENT HAD ACTIVATED THE PENCIL TO CAUTERIZE TISSUE AND WHEN STOPPED PRESSING THE BUTTON AND BRINGING THE PENCIL OUT OF THE PELVIS, A FLAME SPARK WAS WITNESSED FROM THE PENCIL FOR A FEW SECONDS. THERE WAS A SMALL AMOUNT OF MATERIAL DEBRIS ON THE TIP OF THE PENCIL BUT THE PENCIL WAS NOT BEING ACTIVATED WHEN THE FLAME WAS NOTED. REMOVED THE PENCIL FROM THE FIELDS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103069 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI NEW DEANTRONICS LTD SEP6000 2007042X 10884521750913

    Patients

    Seq Age Sex Outcome Treatment
    1