BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13698641 · Received March 8, 2022

    Report

    Report Number
    2027111-2022-00454
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 7, 2022
    Report Date
    May 26, 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
    SP
    Reporter Occupation
    PHARMACIST
    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: NEPHRECTOMY. DETAILED DESCRIPTION OF EVENT: EVENT 1 OF 2: (B)(4). EVENT 2 OF 2: (B)(4). WHEN THE DOCTOR TRY TO CUT DURING THE SURGERY, THE SCISSORS DOESN´T CUT PROPERLY. THERE WAS NO CHANGES IN HEALTH RESULTING FROM THE EVENT. THE DOCTOR CHANGE THE SCISSOR FOR ANOTHER ONE, AND THIS OTHER ONE ALSO DID NOT WORK PROPERLY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE DEVICE DID NOT WORK, IT DID NOT CUT, THEY CHANGED SEVERAL SCISSORS (THE SCISSORS DOESN'T CUT FROM THE START OF THE SURGERY). VERY LITTLE TIME (THE DOCTOR TRY TO CUT TWO OR THREE TIMES AND IT DOESN'T CUT PROPERLY, AFTER THIS THE DOCTOR CHANGE THE SCISSOR FOR ANOTHER ONE). SCISSORS WERE NOT USED TO CUT STAPLES, THEY WERE STARTING A SURGERY (NEPHRECTOMY), ACCORDING TO THE DOCTOR, THEY DO NOT CUT (THE DOCTOR TRY TO CUT NORMAL TISSUE, NOT STAPLES AND LAP BAND). 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: NEPHRECTOMY. DETAILED DESCRIPTION OF EVENT: EVENT 1 OF 2: 2022-000384 - MFR 2027111-2022-00453. EVENT 2 OF 2: 2022-000388 - MFR 2027111-2022-00454. WHEN THE DOCTOR TRY TO CUT DURING THE SURGERY, THE SCISSORS DOESN´T CUT PROPERLY. THERE WAS NO CHANGES IN HEALTH RESULTING FROM THE EVENT. THE DOCTOR CHANGE THE SCISSOR FOR ANOTHER ONE, AND THIS OTHER ONE ALSO DID NOT WORK PROPERLY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16FEB22: THE DEVICE DID NOT WORK, IT DID NOT CUT, THEY CHANGED SEVERAL SCISSORS (THE SCISSORS DOESN'T CUT FROM THE START OF THE SURGERY). VERY LITTLE TIME (THE DOCTOR TRY TO CUT TWO OR THREE TIMES AND IT DOESN'T CUT PROPERLY, AFTER THIS THE DOCTOR CHANGE THE SCISSOR FOR ANOTHER ONE). SCISSORS WERE NOT USED TO CUT STAPLES, THEY WERE STARTING A SURGERY (NEPHRECTOMY), ACCORDING TO THE DOCTOR, THEY DO NOT CUT (THE DOCTOR TRY TO CUT NORMAL TISSUE, NOT STAPLES AND LAP BAND). 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
    1855330 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1433357 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose