BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHOLT-GEISS SUTURE FCPS #6 CVD225MM

    MDR report key: 6480954 · Received April 11, 2017

    Report

    Report Number
    9610612-2017-00190
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 9, 2017
    Report Date
    September 13, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: IRELAND. IT WAS REPORTED THAT WHEN DIVIDING THE COLON, PREPARING ONE END FOR ANASTOMOSIS, CUT MESENTERIC ARTERY, CHECKED FOR BLOOD SUPPLY CLAMPED WITH BJ026R. THE VESSEL CONTINUED TO BLEED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT. HERE WE FOUND NO SIGNS OF FAILURE. THE TONG BITS CLOSE ELASTICALLY TO AT LEAST 2/3 OF THE WORKING SURFACE DURING LATCHING UP TO THE LAST CATCH. THE JAW IS LATERALLY OVERLAPPING. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USER RELATED. RATIONAL: THER ARE NO HINTS OF A PRE-DAMAGE OR SIMILAR. ACCORDING TO THE QUALITY STANDARD QSTD RING FORCEPS/CLAMPS SA-DDDD-M-5-2-04-110-0-G-EN THERE ARE NO HINTS OF A FAILURE. A MATERIAL DEFECT CAN BE EXCLUDED. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261628 OVERHOLT-GEISS SUTURE FCPS #6 CVD225MM HAEMOSTATIC FORCEPS HTD AESCULAP AG BJ026R 4507899189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other