BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 10823475 · Received November 11, 2020

    Report

    Report Number
    2027111-2020-00612
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    January 14, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THAT THE UNIT DID NOT FUNCTION AS INTENDED. ENGINEERING OBSERVED THAT THERE WAS A GAP BETWEEN THE TIPS OF THE BLADES. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE SCISSORS WERE UNABLE TO CUT DUE TO THE GAP THAT WAS OBSERVED BETWEEN THE TIPS OF THE BLADES ON THE EVENT UNIT. IT IS UNKNOWN WHETHER THE GAP WAS A PRE-EXISTING NON-CONFORMANCE OR CAUSED BY USE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: ADHESIOLYSE. CER 1 OF 2: (B)(4). CER 2 OF 2: (B)(4). HET MATERIAAL FUNCTIONEERT NIET ZOALS HET MOET. TRANSLATION AME: DEVICE DOESN'T FUNCTION AS INTENDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 29OCT2020: THE PROCEDURE WAS AN ADHESIOLYSE. HIS COMPLAINT WAS THAT THE SCISSORS WERE NOT AS SHARP AS NORMAL. ON THE FIRST SCISSORS, HE USED MONOPOLAR ENERGY. ON THE SECOND HE DIDN¿T BUT HE HAD THE SAME IMPRESSION. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: OKÉ.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    CER 1 OF 2: 2020-002474; CER 2 OF 2: 2020-002475. PROCEDURE PERFORMED: ADHESIOLYSE. HET MATERIAL FUNCTIONEERT NIET ZOALS HET MOET. TRANSLATION AME: DEVICE DOESN'T FUNCTION AS INTENDED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 29OCT2020: THE PROCEDURE WAS AN ADHESIOLYSE. HIS COMPLAINT WAS THAT THE SCISSORS WERE NOT AS SHARP AS NORMAL. ON THE FIRST SCISSORS, HE USED MONOPOLAR ENERGY. ON THE SECOND HE DIDN'T BUT HE HAD THE SAME IMPRESSION. INTERVENTION: UNKNOWN. PATIENT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289144 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1387163 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1