BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCH KOH-EFFICIENT

    MDR report key: 4174972 · Received August 8, 2014

    Report

    Report Number
    1627186-2014-00007
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    September 7, 2013
    Report Date
    August 6, 2014
    Manufacturer
    COOERSURGICAL INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OR RETURN THE ACTUAL PRODUCT INVOLVED IN THE EVENT. DHR REVIEW FOR SELECTED LOTS 122649, 126866, 140912, 154762, 154764, AND 155273 SHOW THE PRODUCTS MET ALL APPROVED RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE BEFORE THEY WERE RELEASED. THERE WERE NO MANUFACTURING ISSUES DURING THE MANUFACTURE OF THE LOTS. THERE HAVE NOT BEEN ANY RELATED DESIGN OR SPECIFICATION CHANGES OVER THE LAST TWO YEARS. SAMPLE PRODUCT FORM FINISHED GOODS (FG) WAS EVALUATED AND THE REPORTED CONDITION COULD NOT BE DUPLICATED. ALL PRODUCTS TESTED EXCEEDED THE MINIMUM PULL FORCE SPECIFICATION OF 10 LBS. THE FINISHED GOODS SAMPLED MEET ALL APPROVED RELEASE SPECIFICATIONS. THERE WERE NO INDICATIONS OF NONCONFORMANCE. A 1 YEAR HISTORICAL REVIEW OF COMPLAINTS SHOWS 2 SIMILAR COMPLAINTS WITHIN THE SAME PRODUCT FAMILY. THE REPORTED CONDITION COULD NOT BE CONFIRMED AS THE ACTUAL SAMPLE WAS NO RETURNED. THIS COMPLAINT CONDITION MAY BE RE-OPENED AND RE-EVALUATED IF THE SAMPLE BECOMES AVAILABLE. SIMILAR PAST COMPLAINT INVESTIGATIONS BY QUALITY ENGINEERING CONCLUDED THE LIKELY CAUSE OF THE REPORTED CONDITION TO BE EXCESSIVE FORCE DURING USE. BASED ON THE EVALUATION AND TESTING OF FINISHED GOODS (FG) SAMPLES, DHR REVIEW, AND OVERALL PRODUCT KNOWLEDGE, THE LIKELY CAUSE OF THE REPORTED COMPLAINT CONDITION IS EXCESSIVE MANIPULATION AND FORCE APPLIED BY THE END USER. COOPERSURGICAL WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR ANY TRENDS. NOTE: THIS COMPLAINT APPEARS TO BE DUPLICATE TO E-COMPLAINT 2014-04-0000033.

    Description of Event or Problem · 1

    AS REPORTED ON MEDWATCH FORM (MW5035729) - "A RING ON A DEVICE TO REMOVE A UTERUS VIA ROBOTIC SURGERY BROKE OFF AND WAS LEFT ON THE PATIENT'S CERVIX. REASON FOR USE WAS TO ASSIST IN THE REMOVAL OF THE UTERUS VIA ROBOTIC SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471829 ARCH KOH-EFFICIENT KC-ARCH LKF COOERSURGICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other