BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 8250736 · Received January 15, 2019

    Report

    Report Number
    9610612-2019-00031
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 5, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT IS NOT AVAILABLE FOR INVESTIGATION. THE PRODUCT DOES NOT REQUIRED BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. NO PRODUCT AVAILABLE AND THEREFORE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSES. WE ASSUME THAT THE CAUSES OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. DUE TO THE LACK OF DATA AND WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT CAUSE. ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. THERE IS THE POSSIBILITY FOR AN USAGE ERROR. THE BROKEN OFF TIP COULD HAVE BEEN CAUSED DUE TO IMPROPER HANDLING BY A MECHANICAL OVERLOAD SITUATION. THERE IS ALSO THE POSSIBILITY FOR AN USAGE ERROR. THE BROKEN OFF TIP COULD HAVE BEEN CAUSES DUE TO AN IMPROPER HANDLING BY A MECHANICAL OVERLOAD SITUATION. THERE IS ALSO THE POSSIBILITY FOR PRE-DAMAGE OR SIMILAR DUE TO PREVIOUS SURGERIES. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE PRODUCT SHOULD BE PROVIDED FOR EXAMINATION. FURTHERMORE ACCORDING THE INSTRUCTION FOR USE THE FOLLOWING POINTS MUST BE OBSERVED: EXCERPT FOR THE IFU: PRIOR TO EACH USE, INSPECT THE PRODUCT FOR LOOSE, BENT BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS. DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DETECTIVE. SET ASIDE THE PRODUCT IF IT IS DAMAGED. REPLACE ANY DAMAGED COMPONENTS IMMEDIATELY WITH ORIGINAL SPARE PARTS. TO AVOID DAMAGE TO THE WORKING END. CAREFULLY INSERT THE PRODUCT THROUGH THE WORKING CHANNEL (E.G. TROCAR) AFTER EACH COMPLETE CLEANING, DISINFECTING AND DRYING CYCLE, CHECK THAT THE INSTRUMENT IS DRY, CLEAN, OPERATIONAL AND FREE OF DAMAGE (E.G. BROKEN INSULATION OR CORRODED, LOOSE, BENT, BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS). IMMEDIATELY PUT ASIDE DAMAGED OR INOPERATIVE PRODUCTS AND SEND THEM TO AESCULAP TECHNICAL SERVICE. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE CERAMIC ELECTRODE TIP. DURING A LAPAROSCOPIC PROCEDURE, THE CAUTERY WAS BEING USED AND SUDDENLY DID NOT WORK. THE TIP WAS NOTED AS NOT FUNCTIONING AND AN X-RAY WAS REQUIRED TO LOCATE AND RETRIEVE THE TIP. THERE WAS A SURGICAL DELAY OF 30 MINUTES. NO FURTHER PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40353 CERAMIC ELECTRODE TIP J-HK F/GK372R ENDOSCOPY GEI AESCULAP AG GK383R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAUTERY DEVICE| CAUTERY DEVICE