BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13542980 · Received February 16, 2022

    Report

    Report Number
    2027111-2022-00373
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 27, 2022
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 RETURNED UNIT WAS UNABLE TO CUT CONSISTENTLY ACROSS THE ENTIRE LENGTH OF THE BLADE. ENGINEERING OBSERVED A SMALL GAP BETWEEN THE TIPS OF THE BLADES. BASED ON THE CONDITION OF THE EVENT UNIT AND DESCRIPTION OF THE EVENT, THE SCISSORS WERE UNABLE TO CUT DUE TO THE GAP THAT WERE OBSERVED BETWEEN THE TIPS OF THE BLADES ON THE RETURNED UNIT. HOWEVER, THE EXACT ROOT CAUSE OF THE GAP COULD NOT BE DETERMINED BASED ON THE EVALUATION OF THE RETURNED UNIT. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: HYSTERECTOMY BY LAPAROSCOPY. DETAILED DESCRIPTION OF EVENT: EVENT 1 OF 3: 2022-000141, EVENT 2 OF 3: 2022-000142, EVENT 3 OF 3: 2022-000143. IT'S WITH 3 UNITS OF CB030: LOT 1427244, LOT 1427761, LOT 1425911. ALL PRODUCTS ARE AVAILABLE TO RETURN. THE INCIDENT HAPPENED THIS MORNING AND IT WAS DURING AN HYSTERECTOMY BY LAPAROSCOPY. THE SURGEON SAID THE SCISSORS DIDN'T CUT WELL ENOUGH AT THE EXTREMITY OF THE JAWS. HE HAS CHANGED SCISSOR (4 TIMES) AND THE PATIENT IS SAFE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT TYPE OF INTERVENTION: CHANGE OF DEVICE

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: HYSTERECTOMY BY LAPAROSCOPY DETAILED DESCRIPTION OF EVENT: EVENT 1 OF 3: 2022-000141 - MFR 2027111-2022-00373, EVENT 2 OF 3: 2022-000142 - MFR 2027111-2022-00374, EVENT 3 OF 3: 2022-000143 - MFR 2027111-2022-00375. IT'S WITH 3 UNITS OF CB030: LOT 1427244, LOT 1427761, LOT 1425911. ALL PRODUCTS ARE AVAILABLE TO RETURN. THE INCIDENT HAPPENED THIS MORNING AND IT WAS DURING AN HYSTERECTOMY BY LAPAROSCOPY. THE SURGEON SAID THE SCISSORS DIDN'T CUT WELL ENOUGH AT THE EXTREMITY OF THE JAWS. HE HAS CHANGED SCISSOR (4 TIMES) AND THE PATIENT IS SAFE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. TYPE OF INTERVENTION: CHANGE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528921 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1427244 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown