BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH-EFFICIENT,ARCH,4.0CM

    MDR report key: 5612688 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00073
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    May 7, 2015
    Report Date
    February 3, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED FOR EVALUATION, HOWEVER WE ARE AWAITING PHOTO'S OF THE DEVICE FOR VISUAL INSPECTION FROM CUSTOMER . ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT" (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). *INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED, X-REVIEW DHR, INSPECT RETURNED SAMPLES, INSPECT STOCK PRODUCT. *ANALYSIS AND FINDINGS: LOT NUMBER FOR PRODUCT KC-ARCH-40 (KOH-EFFICIENT,ARCH,4.0CM), IN COMPLAINT IS UNKNOWN. REVIEW OF HISTORICAL SHIPMENTS TO CUSTOMER SHOWS FOUR SHIPMENTS FROM LOTS 154764, 150523, 142457 AND 139069 THAT WERE MANUFACTURED IN 2013 AT STAFFORD FACILITY. DHRS REVIEW SHOW ALL 4 LOTS WERE MANUFACTURED AND TESTED PER ESTABLISHED PROCEDURES. THERE WERE NO NON-CONFORMANCES OR ISSUES IDENTIFIED DURING MANUFACTURING/TESTING OF LOTS. THE FOLLOWING REVIEWS HAVE BEEN COMPLETED DURING THE COURSE OF REPORT INVESTIGATION: ·100% PULL-TESTING: REVIEW OF THE PULL-TEST DATA FOR ALL 4 LOTS WERE PERFORMED AND THERE WERE NO REJECTIONS OBSERVED. ALL ASSEMBLIES MET THE 10 LBF MINIMUM PULL-FORCE SPECIFICATION. ·SERVICE/PREVENTATIVE MAINTENANCE (PM) RECORDS: PRODUCTION ASSEMBLY EQUIPMENT SERVICE AND (PM) RECORDS WERE REVIEWED FROM PRESENT TO THE INCIDENT DATE ((B)(6) 2015), ON BOTH THE KOH-CUP & ARCH BODY ASSEMBLY AND PULL-TEST STATIONS, THERE WERE NO ISSUES OBSERVED. ·GLUE/PRIMER BATCH RECORDS: ALL RECORDS FOR GLUE/PRIMER LOTS WERE REVIEWED WITH NO ISSUES OBSERVED. ·DRAWINGS, KOH- CUP AND ARCH BODY: DRAWING REVIEW OF SUB-COMPONENTS WAS PERFORMED WITH NO ISSUES OBSERVED. ·MOLDING/ASSEMBLY PROCEDURE: THE MOLDING/ASSEMBLY PROCEDURE IN EXISTENCE IN 2013 WAS EVALUATED AND NO ISSUES OBSERVED. PRIOR INVESTIGATION INTO THE POTENTIAL ROOT CAUSE FOR CUP SEPARATION SHOWED THAT 30 EA. OF KC-ARCH PRODUCTS WHERE GLUE/PRIMER WAS USED, PULLED FROM FINISHED GOODS AND PULL-TESTED TO FAIL. ALTHOUGH THERE WAS SOME VARIABILITY IN THE TEST RESULTS FOR PULL TESTING, IT WAS NOTED THAT ALL SAMPLES WERE ABOVE THE MINIMUM PULL FORCE OF 10 LBF. TESTING OF SAMPLES WAS UNABLE TO DUPLICATE THE REPORTED FAILURE; THEREFORE, THE ROOT CAUSE ANALYSIS FOR THIS EVENT HAS CONCLUDED THE LIKELY CAUSE TO BE EXCESSIVE MANIPULATION AND FORCE AT POINT OF USE. *CORRECTION AND/OR CORRECTIVE ACTION CURRENT LOTS MANUFACTURED IN (B)(4) USE CORONA TREATED PARTS FOR ASSEMBLY, THAT HAVE BEEN VALIDATED TO PROVIDE EVEN STRONGER BONDING BETWEEN KOH CUP AND ARCH. RISK REVIEW AND ANALYSIS WERE PERFORMED BY COOPERSURGICAL RISK MANAGEMENT PERSONNEL; THE BASIS FOR THE REVIEW INCLUDES COMPLAINT HISTORY, THE INSTALL BASE FOR THE ARCH KOH-EFFICIENT, AND THE OPPORTUNITIES OR THE PROCEDURAL VOLUMES OF THE MARKETED DEVICE. THE COMPLETE RISK REVIEW YIELDS; WITH THE DESIGN OF THE DEVICE, 100% IN-PROCESS TESTING AND PROPER SURGICAL TECHNIQUE, THE RISK POTENTIAL FOR A HAZARDOUS SITUATION IS "LOW AND UNLIKELY TO OCCUR". WHILE THE RISK POTENTIAL IS LOW AND UNLIKELY TO OCCUR, THE POTENTIAL HAZARD ASSOCIATED WITH THE REPORTED COMPLAINT CONDITION IS SERIOUS; AS WITH ANY FOREIGN BODY LEFT IN THE PATIENT'S BODY, THERE IS POTENTIAL TO CAUSE INFECTION. EVEN THOUGH THE REPORTED COMPLAINT CONDITION IS CONSIDERED TO BE SERIOUS, IT IS CONSIDERED AN UNCOMMON EVENT. THE CURRENT MITIGATIONS FOR THE ARCH KOH-EFFICIENT SYSTEM ARE EFFECTIVE IN ADDRESSING THE POTENTIAL HAZARD ASSOCIATED WITH THE REPORTED COMPLAINT CONDITION. WITH THESE FACTS IN MIND, NO FURTHER ACTION IS NECESSARY AT THIS PRESENT TIME. COOPERSURGICAL WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR TRENDS. FORMAL TRACKING AND TRENDING PER ESTABLISHED PROCEDURE.

    Description of Event or Problem · 1

    PER MEDWATCH MW5056807 RECEIVED 10/23/2015 : "SURGEON USED THE ARCH -KOH EFFICIENT 4.0 CM (UTERINE MANIPULATOR) COOPERSURGICAL. THIS IS A DISPOSABLE MEDICAL DEVICE USED DURING A LAP SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY. THE BLUE CUP BROKE OFF FROM MEDICAL DEVICE WITHOUT THE SURGEON OR HOSPITAL STAFF AWARENESS. THE BLUE CUP WAS FOUND 5 MONTHS LATER: RETAINED IN PT. THE BLUE CUP SHOULD NOT HAVE BROKEN OFF. TWO SUPRAPUBIC 5MM PORTS AND AN INCISION IN THE UMBILICUS THROUGH THE PERITONEUM. THROUGH THIS INCISION A GELPOINT RETRACTOR WAS PLACED." REF E-COMPLAINT : (B)(4).

    Description of Event or Problem · 1

    PER MEDWATCH MW5056807 RECEIVED 10/23/2015 : "SURGEON USED THE ARCH -KOH EFFICIENT 4.0 CM (UTERINE MANIPULATOR) COOPERSURGICAL. THIS IS A DISPOSABLE MEDICAL DEVICE USED DURING A LAP SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY. THE BLUE CUP BROLE OFF FROM MEDICAL DEVICE WITHOUT THE SURGEON OR HOSPITAL STAFF AWARENESS. THE BLUE CUP WAS FOUND 5 MONTHS LATER: RETAINED IN PT. THE BLUE CUP SHOULD NOT HAVE BROKEN OFF. TWO SUPRAPUBIC 5 MM PORTS AND AN INCISION IN THE UMBILICUS THROUGH THE PERITONEUM. THROUGH THIS INCISION A GELPOINT RETRACTOR WAS PLACED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266003 KOH-EFFICIENT,ARCH,4.0CM KOH-EFFICIENT,ARCH,4.0CM LKF COOPERSURGICAL, INC. KC-ARCH-40 154764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R