BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH-EFF,ARCH,4.0CM,HARMNC

    MDR report key: 11768720 · Received May 4, 2021

    Report

    Report Number
    1216677-2021-00078
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    March 24, 2021
    Report Date
    February 6, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    UDI-DI
    00888937015218
    PMA / PMN Number
    K954311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION NO SAMPLE RETURNED REVIEW DHR. ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 07/07/18 UNDER WORK ORDER 252078. MANUFCTRNG RECORD REVW. DHR - 252078 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVW. INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERV. HISTORY RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HIST. COMPLAINT REVW. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. FUNCTNL EVAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT WAS NOT BEEN RETURNED TO COOPERSURGICAL. HOWEVER, THE COMPLAINT CONDITION IS VERY SIMILAR TO OTHER COMPLAINTS AS MENTIONED EARLIER. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, WITH THE INFORMATION PROVIDED IN THE COMPLAINT. COMPLAINT PRODUCT WAS NOT RETURNED FOR INVESTIGATION. TO MITIGATE CUP DETACHMENT, CSI STAFFORD HAS IMPLEMENTED 100% IN PROCESS INSPECTION OF THE PRODUCT VIA BEND TEST, FOLLOWED BY AN AQL QC INSPECTION REQUIRING THE UNITS ALSO PASS BEND/PULL TEST. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE ROOT CAUSE CANNOT BE RELIABLY DETERMINED WITH THE INFORMATION PROVIDED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    THE CUP IS BROKEN IN THREE PARTS, KOH-EFF ARCH 4-0CM HARMNC KCS-ARCH-40 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    PER REPORT- EVENT INFORMATION: TRANSLATION IN ENGLISH : "THE CUP IS BROKEN IN THREE PARTS". FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. 04/12/2021- UPDATE: FOLLOW-UP RESPONSE STATED- NO INVOLVEMENT FOR THE PATIENT. WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? PATIENT INJURY? NO CONDITION REPORTED FOR THE PATIENT. NO ADDITIONAL MEDICAL ATTENTION. WAS REPORTED CONDITION DURING PROCEDURE? NO. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? ROBOTIC HYSTERECTOMY. 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? THE PROBLEM OCCURRED AT THE END OF SURGERY, NO PROBLEM DURING. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? NO DELAY. KOH-EFF ARCH 4-0CM HARMNC, KCS-ARCH-40. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670492 KOH-EFF,ARCH,4.0CM,HARMNC KOH-EFF,ARCH,4.0CM,HARMNC HEW COOPERSURGICAL, INC. KCS-ARCH-40 252078 00888937015218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other