BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 4.0 SOFT KOH-EFF

    MDR report key: 7952714 · Received October 10, 2018

    Report

    Report Number
    1216677-2018-00048
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 14, 2018
    Report Date
    November 22, 2019
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HEW
    PMA / PMN Number
    K180429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION AND X-NO SAMPLE RETURNED. ANALYSIS AND FINDINGS: QUALITY ENGINEERING, RESEARCH AND DEVELOPMENT, MARKETING, AND PRODUCT SURVEILLANCE CONDUCTED AN INVESTIGATION INTO THE ADVINCULA SOFT KOH-EFFICIENT PRODUCT COMPLAINT (B)(4) FROM UNIVERSITY OF MD OB/GYN, WHERE SMALL FRAGMENTS OF THE SOFT CUP EITHER BECAME DAMAGED OR MELTED, DISENGAGING FROM THE CUP. THIS EVALUATION WAS BASED ON A REVIEW OF COMPLAINT HISTORY, A DEVICE HISTORY RECORD REVIEW, AND INVESTIGATION OF RETURNED ADVINCULA SOFT KOH-EFFICIENT PRODUCT FROM SIMILAR COMPLAINTS. A REVIEW OF COMPLAINTS INDICATED THAT THERE WERE SEVEN SIMILAR COMPLAINTS ON FILE FOR THIS REPORTED CONDITION. THE LOT NUMBER WAS NOT REPORTED FOR THIS PARTICULAR COMPLAINT, THEREFORE, A REVIEW OF THE LOT INVENTORY AND DHR WERE NOT ABLE TO BE REVIEWED. THIS COMPLAINT IS CONFIRMED BASED UPON ITS PART OF THE PARENT INVESTIGATION AS INDICATED IN CAPA 722. REPLICATION OF THE REPORTED CONDITION MAY BE ATTRIBUTED TO TECHNIQUE DURING A COLPOTOMY, IN WHICH CONSTANT MOVEMENT OF THE ELECTROSURGICAL UNIT (ESU) CUTTING TIP IS NECESSARY. FOR EXAMPLE, IF THE END USER DOES NOT KEEP THE ESU TIP MOVING AND REMAINS IN ONE PLACE ON TISSUE FOR AN EXTENDED PERIOD OF TIME, THE ADVINCULA SOFT CUP MATERIAL MAY BEGIN TO MELT. CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL IS EXPLORING OTHER POTENTIAL SOFT MATERIALS WITH A HIGHER MELTING TEMPERATURE - REFERENCE CAPA 722. X-NONE REASON: THE PRODUCT MET THE REQUIRED RELEASE SPECIFICATIONS PER DHR REVIEW. NO RE-TRAINING REQUIRED. WAS THE COMPLAINT CONFIRMED? YES. CAPA REQUIRED? #: 722. PREVENTATIVE ACTION ACTIVITY: REFERENCE CAPA 722. REFERENCEE-COMPLAINT-(B)(4). SUBJECT REPORT NUMBER: (B)(4).

    Description of Event or Problem · 0

    " THE SOFT CUP COMPLETELY MELTED, AND WAS TO THE POINT OF THE PLASTIC BUBBLING. PIECES WERE ACTUALLY MELTING ON THE INSIDE OF THE PATIENT." REF E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT RETURNED FOR EVALUATION. COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "THE SOFT CUP COMPLETELY MELTED, AND WAS TO THE POINT OF THE PLASTIC BUBBLING. PIECES WERE ACTUALLY MELTING ON THE INSIDE OF THE PATIENT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792993 STERILE 4.0 SOFT KOH-EFF KOH-EFFICIENT HEW COOPERSURGICAL INC. AD750SC-KE40 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other