BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFFICIENT,RUMI,3.0CM

    MDR report key: 7960659 · Received October 12, 2018

    Report

    Report Number
    1216677-2018-00057
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    July 31, 2018
    Report Date
    February 15, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    UDI-DI
    00888937015072
    PMA / PMN Number
    K954311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION; REVIEW DHR; INSPECT RETURNED SAMPLES: *ANALYSIS AND FINDINGS DHR REVIEW OF WO# (B)(4) FOR PN KC-RUMI-30 SHOWS 200 BOXES WERE MADE IN FEB 2018 AT CSI STAFFORD FACILITY. EACH BOX CONTAINS FIVE EACH OF THE ASSEMBLED KC-RUMI-30 PARTS EACH ASSEMBLED WITH ONE OCCLUDER PN 23670-1. THERE WERE 3 LOTS (243557, 242842, 244109) OF OCCLUDER USED FOR ASSEMBLING THE FINISHED GOODS. INSPECTIONS/TESTS WERE PERFORMED AT FOUR LEVELS FROM MOLDING THROUGH ASSEMBLY INTO FINISHED PARTS: 1. AFTER EACH LOT WAS MOLDED, 100% VISUAL INSPECTIONS WERE DONE AND BALLOON-TESTED FOR AIR-LEAKS. 2. QC TESTS OF OCCLUDER LOTS INCLUDED LEAK TESTING (8 EA) BY INJECTING 200CC SALINE IN EACH. 3. AFTER ASSEMBLY, IN-PROCESS VISUAL INSPECTION IS PERFORMED IN FG LOT. NON-CONFORMING PARTS ARE CULLED OUT INCLUDING CUTS IN THE OCCLUDER. 4. QC COMPLETES VISUAL INSPECTIONS WITH SAMPLES FROM ASSEMBLED FG LOT. THE COMPLAINT DETAIL MENTIONS THAT THE INITIAL TEST OF THE "DONUT" WHICH IS CONSIDERED THE OCCLUDER, WENT SUCCESSFULLY. IT WAS ONLY AFTER THE USE OF THE DEVICE INSIDE OF THE PATIENT THAT THE OCCLUDER STARTED TO LEAK. THE LEAK WAS COMING FROM TWO PIN HOLES. IT IS HIGHLY PROBABLE THAT THE OCCLUDER MAY HAVE BEEN PUNCTURED WITH A SHARP OBJECT, CAUSING THE LEAK, AS IT WAS EVIDENT THAT THE OCCLUDER WAS NOT LEAKING AT THE TIME OF TESTING. WITH MANUFACTURING PROCESS 100% TESTING EACH OCCLUDER WITH AIR LEAK TEST, AND AS WELL AS THE OCCLUDER NOT LEAKING DURING TEST OUTSIDE OF THE PATIENT, IT IS UNLIKELY THAT THE LEAK OF THE OCCLUDER CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE. IN ADDITION, THERE IS NO EXISTING SOURCE OF HOLES/ CUTS IDENTIFIED AFTER KOH ASSEMBLIES AT THE FACILITY. A LEAK IN THE OCCLUDER MAY HAVE BEEN CAUSED BY A CUT OR PUNCTURE VIA USAGE ERROR. A 2 YR COMPLAINT HISTORY REVIEW WAS PERFORMED AND THERE WERE OTHER COMPLAINTS WITH LEAKING OCCLUDERS, HOWEVER THOSE COMPLAINTS WERE SHOWN TO HAVE CUTS ON THE OCCLUDERS THAT WERE PUNCTURED WITH SHARP OBJECT. CORRECTION AND/OR CORRECTIVE ACTION: COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. NOT DETERMINED TO BE A MANUFACTURING ISSUE. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    DOCTOR TESTED THE "DONUT" OUTSIDE OF THE PATIENT AND IT WAS FINE. BEGAN TO USE IT INSIDE THE PATIENT, AND ONLY ONCE IT WAS FULLY INFLATED DID IT START TO LEAK - SPRINGING OUT LIKE A FOUNTAIN ONTO THE OR FELLOW. KOH-EFFICIENT,RUMI,3-0CM KC-RUMI-30 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED FOR EVALUATION BY THE CUSTOMER. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILLED. (B)(4).

    Description of Event or Problem · 1

    DOCTOR "TESTED THE "DONUT" OUTSIDE OF THE PATIENT AND IT WAS FINE. BEGAN TO USE IT INSIDE THE PATIENT, AND ONLY ONCE IT WAS FULLY INFLATED DID IT START TO LEAK - SPRINGING OUT LIKE A FOUNTAIN ONTO THE OPERATING ROOM FELLOW." INCREASED LENGTH OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803674 KOH-EFFICIENT,RUMI,3.0CM KOH-EFFICIENT,RUMI,3.0CM HEW COOPERSURGICAL, INC. KC-RUMI-30 244093 00888937015072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other