BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13509989 · Received February 10, 2022

    Report

    Report Number
    2027111-2022-00359
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    January 11, 2022
    Report Date
    April 25, 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
    GA, US
    Reporter Occupation
    NURSE
    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: INGUINAL HERNIA REPAIR. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 3: (B)(4), CB030, LOT #1432062 (1 EA). COMPLAINT 2 OF 3: (B)(4), CB030, LOT #1432062 (1 EA). COMPLAINT 3 OF 3: (B)(4), CB030, LOT #1432559 (1 EA). 3 EA. UNITS OF CB030 BLADES DID NOT CUT DURING USE ON TISSUE IN A CASE. THE FAILURE TO CUT WAS NOTICED UPON INITIAL USE OF EACH PAIR OF SCISSORS. THE CASE WAS COMPLETED WITH THE THIRD PAIR OF SCISSORS BY USING THE MIDDLE OF THE BLADES TO CUT. THERE WAS NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE THIRD UNIT OF CB030 USING THE CAUTERY FUNCTION INSTEAD OF CUTTING.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: INGUINAL HERNIA REPAIR DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 3: #(B)(4), LOT #1432062 (1 EA) - MFR 2027111-2022-00360. COMPLAINT 2 OF 3: #(B)(4), LOT #1432062 (1 EA) - MFR 2027111-2022-00359. COMPLAINT 3 OF 3: #(B)(4), LOT #1432559 (1 EA) - MFR 2027111-2022-00361. 3 EA. UNITS OF CB030 BLADES DID NOT CUT DURING USE ON TISSUE IN A CASE. THE FAILURE TO CUT WAS NOTICED UPON INITIAL USE OF EACH PAIR OF SCISSORS. THE CASE WAS COMPLETED WITH THE THIRD PAIR OF SCISSORS BY USING THE MIDDLE OF THE BLADES TO CUT. THERE WAS NO PATIENT INJURY. PRODUCTS ARE AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH THE THIRD UNIT OF CB030 USING THE CAUTERY FUNCTION INSTEAD OF CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119960 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1432062 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown