BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 11766926 · Received May 3, 2021

    Report

    Report Number
    2027111-2021-00476
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 7, 2021
    Report Date
    July 19, 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
    FL, US
    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 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

    PROCEDURE PERFORMED: NA. ELEVEN COMPLAINTS HAVE BEEN MADE FROM THIS COMPLAINT SUBMISSION COMPLAINT #(B)(4) (FIRST DEVICE USED). COMPLAINT #(B)(4) (SECOND DEVICE USED). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 07APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 07APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 27APR2021). COMPLAINT #(B)(4) (STERILE DEVICE RETURNED THAT FAILED TESTING ON 28APR2021). STERILE PRODUCT WAS RETURNED AS PART OF COMPLAINT #2021-000259. PER [NAME], APPLIED MEDICAL ENGINEER II, UPON INVESTIGATION OF THE STERILE UNITS, TWO OF THE STERILE UNITS "FAILED SCISSOR CUT TESTING PERFORMED 07APR2021 PER THE [TEST METHOD]." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28APR2021 FROM [NAME], APPLIED MEDICAL ENGINEER II: "TESTING ON THE ADDITIONAL 170 UNITS FROM LOT 1399732 WAS COMPLETED YESTERDAY 27APR2021 AND TODAY 28APR2021. PLEASE OPEN SEVEN NEW COMPLAINTS FOR STERILE UNITS THAT WERE RETURNED BY THE CUSTOMER FROM LOT 1399732. THESE STERILE UNITS WERE ORIGINALLY RETURNED AS PART OF COMPLAINT 2021-000259 AND FAILED SCISSOR CUT TESTING PER THE [TEST METHOD]. SIX OF THE UNITS WERE FOUND DURING TESTING PERFORMED ON 27APR2021 AND ONE WAS FOUND DURING TESTING PERFORMED ON 28APR2021." INTERVENTION: NA (STERILE UNITS, NO PATIENT CONTACT). PATIENT STATUS: NA.

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: NA. STERILE PRODUCT WAS RETURNED AS PART OF COMPLAINT # (B)(4). PER [NAME], APPLIED MEDICAL ENGINEER II, UPON INVESTIGATION OF THE STERILE UNITS, TWO OF THE STERILE UNITS "FAILED SCISSOR CUT TESTING PERFORMED (B)(6) 2021 PER THE SCISSOR ROUGH ACTUATION AND CUT TEST TM-4021167, REV. B." INTERVENTION: NA (STERILE UNITS, NO PATIENT CONTACT). PATIENT STATUS: NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663953 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1399732 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1