BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 3.0 SOFT KOH-EFF

    MDR report key: 8355234 · Received February 20, 2019

    Report

    Report Number
    1216677-2019-00032
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 28, 2019
    Report Date
    December 4, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K180429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED, X-REVIEW DHR. ANALYSIS AND FINDINGS: NO PRODUCT OR LOT NUMBER INVOLVED SPECIFICALLY TO THIS COMPLAINT. HOWEVER, THE COMPLAINT PERTAINS TO THE AD750SC-KE30, WHICH ARE THE SOFT CUPS ADVINCULA DELINEATOR. A 2 YEAR COMPLAINT HISTORY SHOWS THAT THERE ARE OTHER SIMILAR COMPLAINTS ON FILES FOR THE CONDITION OF MELTING CUPS. FOR THOSE COMPLAINTS, PARTS OF THE SOFT CUPS WERE MELTING. QUALITY ENGINEERING, RESEARCH AND DEVELOPMENT, MARKETING, AND PRODUCT SURVEILLANCE CONDUCTED AN INVESTIGATION INTO 4 ADVINCULA SOFT KOH-EFFICIENT PRODUCT COMPLAINTS (2018-11-0000113, 2018-11-0000117, 2018-11-0000120, & 2018-12-0000210) FROM KAISER, WHERE SMALL FRAGMENTS (~ 1 MM) 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 FILE REVIEW, AND PHOTOGRAPHS OF THE APPLIED ADVINCULA SOFT KOH-EFFICIENT PRODUCTS. IN THESE AFOREMENTIONED COMPLAINTS, 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. DUE TO THE COMPLAINT NOT BEING RETURNED AND NO LOT NUMBER WAS PROVIDED, A FULL INVESTIGATION CANNOT BE PERFORMED. SHOULD COMPLAINT RETURN IN THE FUTURE FOR EVALUATION, ANY PERTINENT INFORMATION WILL BE ADDED TO THE COMPLAINT FILE. 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 (B)(4). RE: SUBJECT REPORT NUMBER: (B)(4).

    Description of Event or Problem · 0

    MELTING DURING USE. DECEMBER 20, 2018 @ 7:30 AM, UCSF MB, SAN FRANCISCO, CA, DR. (B)(6), DELINEATOR SOFT CUP 3.0. REF (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

    MELTING DURING USE, (B)(6) 2018 @ 7:30 AM. (B)(6). DELINEATOR SOFT CUP 3.0. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149465 STERILE 3.0 SOFT KOH-EFF STERILE 3.0 SOFT KOH-EFF HEW COOPERSURGICAL, INC. AD750SC-KE30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other