BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 3.5 SOFT KOH-EFF

    MDR report key: 8110225 · Received November 28, 2018

    Report

    Report Number
    1216677-2018-00077
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 4, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED AND X-REVIEW DHR. ANALYSIS AND FINDINGS: QUALITY ENGINEERING, RESEARCH AND DEVELOPMENT, MARKETING, AND PRODUCT SURVEILLANCE CONDUCTED AN INVESTIGATION INTO 4 ADVINCULA SOFT KOH-EFFICIENT PRODUCT COMPLAINTS (B)(4) 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. A REVIEW OF COMPLAINTS INDICATED THAT THERE WERE FOUR SIMILAR COMPLAINTS ON FILE FOR THIS REPORTED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NO. 227-18 AND 222-18 INDICATED THAT THE UNITS WERE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND DID NOT REVEAL ANY ABNORMALITIES. A REVIEW OF THE PHOTOGRAPHS RECEIVED CONFIRMED THE REPORTED CONDITION. 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-2018-11-0000113 RE: SUBJECT REPORT NUMBER: 3600270000-2019-8004

    Additional Manufacturer Narrative · 0

    *INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR *ANALYSIS AND FINDINGS 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. A REVIEW OF COMPLAINTS INDICATED THAT THERE WERE FOUR SIMILAR COMPLAINTS ON FILE FOR THIS REPORTED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NO. 227-18 AND 222-18 INDICATED THAT THE UNITS WERE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND DID NOT REVEAL ANY ABNORMALITIES. A REVIEW OF THE PHOTOGRAPHS RECEIVED CONFIRMED THE REPORTED CONDITION. 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-2018-11-0000113 RE: SUBJECT REPORT NUMBER: 3600270000-2019-8004

    Description of Event or Problem · 0

    CUSTOMER STATES ON (B)(6) 2018 THEIR WAS MELTING OF KOH SOFT CUP DURING COLPOTOMY. DOCTOR WAS ABLE TO REMOVE ALL PIECES FROM THE PATIENT NOTHING WAS LEFT IN THE PATIENT. E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    CUSTOMER STATES ON (B)(6) 2018 THEIR WAS MELTING OF KOH SOFT CUP DURING COLPOTOMY. DOCTOR WAS ABLE TO REMOVE ALL PIECES FROM THE PATIENT NOTHING WAS LEFT IN THE PATIENT.(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

    CUSTOMER STATES ON (B)(6) 2018 THEIR WAS MELTING OF KOH SOFT CUP DURING COLPOTOMY. DOCTOR WAS ABLE TO REMOVE ALL PIECES FROM THE PATIENT NOTHING WAS LEFT IN THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949409 STERILE 3.5 SOFT KOH-EFF STERILE 3.5 SOFT KOH-EFF HEW COOPERSURGICAL, INC. AD750SC-KE35 227-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other