BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFFICIENT,RUMI,4.0CM

    MDR report key: 14251801 · Received April 29, 2022

    Report

    Report Number
    1216677-2022-00127
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    March 22, 2022
    Report Date
    October 23, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K954311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 11/17/21 UNDER WORK ORDER 312201. MANUFACTURING RECORD REVIEW DHR - 312201 WAS REVIEWED AND NO NON-CONFORMITY, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. A PICTURE WAS PROVIDED SHOWING THAT THE CUP HAD BECOME DETACHED FROM THE HINGE. FUNCTIONAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION NOR VERIFICATION. WITH THE INFORMATION PROVIDED, A ROOT CAUSE ANALYSIS CANNOT BE DEFINITIVELY PERFORMED. IT IS UNKNOWN IF THE CUSTOMER USED A SIZER (KCP) TO DETERMINE THE PROPER SIZE KOH-EFFICIENT TO USE. THIS IS LISTED UNDER THE DFU OF THE PRODUCT (ARCHKOHADV-DFU). THE CUSTOMER WAS REACHED FOR ADDITIONAL INFORMATION ON THE PROCEDURE AND HOW THE DEVICE MAY HAVE BEEN USED, HOWEVER, NO INFORMATION WAS PROVIDED. AS A WAY OF IMPROVING THE MANUFACTURING PROCESS, CSI STAFFORD HAS IMPLEMENTED 100% IN PROCESS INSPECTION OF THE PRODUCT VIA BEND TESTING AND PULL TESTING, FOLLOWED BY AN AQL QC INSPECTION REQUIRING THE THAT THE UNITS ALSO PASS A BEND AND PULL TEST. *CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL INC. IS CURRENLTY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 0

    : COMPLAINT INFORMATION PROVIDED BY CSI SALES. "END OF INSTRUMENT THAT IS SUPPOSED TO BE WELDED TOGETHER BROKE OFF INSIDE PATIENT." FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. APR 21, 2022- FOLLOW-UP RESPONSE *WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? NONE REPORTED *HOW IS PATIENT TODAY? AS BEST AS I KNOW FINE *WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NONE REQUIRED. *WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? *DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? ROBOTIC HYSTERECTOMY. THE CUP THAT CAME OFF HAD TO BE RETRIEVED IN ORDER TO FINISH THE PROCEDURE. * WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES OR OVER ? ROUGHLY A 20 TO 30 MINUTE DELAY IN THE PROCEDURE TIME. (B)(4) KOH-EFFICIENT RUMI 4-0CM KC-RUMI-40 (B)(4)

    Description of Event or Problem · 0

    COMPLAINT INFORMATION PROVIDED BY CSI SALES. END OF INSTRUMENT THAT IS SUPPOSED TO BE WELDED TOGETHER BROKE OFF INSIDE PATIENT. FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. APR 21, 2022. FOLLOW-UP RESPONSE WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? NONE REPORTED. HOW IS PATIENT TODAY? AS BEST AS I KNOW FINE . WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NONE REQUIRED. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? ROBOTIC HYSTERECTOMY. THE CUP THAT CAME OFF HAD TO BE RETRIEVED IN ORDER TO FINISH THE PROCEDURE. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES OR OVER? ROUGHLY A 20 TO 30 MINUTE DELAY IN THE PROCEDURE TIME. 1216677-2022-00127 KOH-EFFICIENT RUMI 4-0CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308767 KOH-EFFICIENT,RUMI,4.0CM KOH-EFFICIENT,RUMI,4.0CM HEW COOPERSURGICAL, INC. KC-RUMI-40 312201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other