BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 3.0 SOFT KOH-EFF

    MDR report key: 8649248 · Received May 29, 2019

    Report

    Report Number
    1216677-2019-00094
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 17, 2019
    Report Date
    December 5, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K180429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: E-COMPLAINT-(B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-REVIEW DHR AND X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: A DHR REVIEW OF LOT NUMBER 264-18 INDICATES THAT THE PRODUCT WAS UNDER DHR WO# (B)(4) FOR THE AD750SC-KE30, AND WAS MADE IN OCT 2018. REVIEW OF THE DHR-AD750SC-KE30-252214 SHOWS NO NONCONFORMITIES ASSOCIATED TO THIS COMPLAINT. 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 SIMILAR COMPLAINTS ON FILE FOR THIS REPORTED CONDITION. THIS COMPLAINT IS CONFIRMED BASED UPON RETURNED UNIT AND 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 NONE. REASON: THE PRODUCT MET THE REQUIRED RELEASE SPECIFICATIONS PER DHR REVIEW. NO RE-TRAINING REQUIRED. COOPERSURGICAL IS EXPLORING OTHER POTENTIAL SOFT MATERIALS WITH A HIGHER MELTING TEMPERATURE - REFERENCE CAPA 722. WAS THE COMPLAINT CONFIRMED? YES. REVIEW AND CLOSURE: CAPA REQUIRED? #: 722 PREVENTATIVE ACTION ACTIVITY: REFERENCE CAPA 722. REFERENCE E-COMPLAINT-(B)(4). RE: SUBJECT REPORT NUMBER: (B)(4).

    Description of Event or Problem · 0

    "THE SOFT CUP MELTED DURING THE PROCEDURE." REF E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    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 MELTED DURING THE PROCEDURE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445628 STERILE 3.0 SOFT KOH-EFF STERILE 3.0 SOFT KOH-EFF HEW COOPERSURGICAL, INC. AD750SC-KE30 264-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other