BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13120261 · Received December 30, 2021

    Report

    Report Number
    2027111-2021-00800
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 9, 2021
    Report Date
    March 1, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    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 UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY DAMAGES OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC INGUINAL HERNIA REPAIR DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 6: #2021-002874 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00795). COMPLAINT 2 OF 6: #2021-002875 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00796). COMPLAINT 3 OF 6: #2021-002876 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00800). COMPLAINT 4 OF 6: #2021-002877 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00799). COMPLAINT 5 OF 6: #2021-002878 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00798). COMPLAINT 6 OF 6: #2021-002879 CB030 LOT # UNKNOWN (MFR # 2027111-2021-00797). LIMITED INFORMATION IS AVAILABLE AT THIS TIME. 5-6 EA UNITS OF CB030 WERE COMPLAINED TO NOT CUT PROPERLY DURING USE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 13DEC2021 FROM [NAME], ACCOUNT MANAGER: IT WAS CONFIRMED THAT 6 UNITS OF CB030 WERE COMPLAINED TO NOT CUT PROPERLY DURING USE. THE CUTTING ISSUES OCCURRED IN ONE CASE. THE LOT NUMBER OF EACH AFFECTED CB030 UNIT IS UNKNOWN. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A WORKING PAIR OF SCISSORS. EVENT DATE AND ALERT DATE IS 09DEC2021. PROCEDURE PERFORMED WAS LAPAROSCOPIC INGUINAL HERNIA REPAIR. IT IS REPORTED THAT THE BLADES SHOWED ISSUES CUTTING TISSUE EARLY IN THE CASE. THE SCISSORS WERE NOTED TO BE NON-FUNCTIONAL UPON INITIAL USE. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A WORKING PAIR OF SCISSORS.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC INGUINAL HERNIA REPAIR. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 6: #: (B)(4) CB030 LOT # UNKNOWN, COMPLAINT 2 OF 6: #: (B)(4) CB030 LOT # UNKNOWN, COMPLAINT 3 OF 6: #: (B)(4) CB030 LOT # UNKNOWN, COMPLAINT 4 OF 6: #: (B)(4) CB030 LOT # UNKNOWN, COMPLAINT 5 OF 6: #: (B)(4) CB030 LOT # UNKNOWN, COMPLAINT 6 OF 6: #: (B)(4) CB030 LOT # UNKNOWN. LIMITED INFORMATION IS AVAILABLE AT THIS TIME. 5-6 EA UNITS OF CB030 WERE COMPLAINED TO NOT CUT PROPERLY DURING USE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 13DEC2021 FROM [NAME], ACCOUNT MANAGER: IT WAS CONFIRMED THAT 6 UNITS OF CB030 WERE COMPLAINED TO NOT CUT PROPERLY DURING USE. THE CUTTING ISSUES OCCURRED IN ONE CASE. THE LOT NUMBER OF EACH AFFECTED CB030 UNIT IS UNKNOWN. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A WORKING PAIR OF SCISSORS. EVENT DATE AND ALERT DATE IS (B)(6) 2021. PROCEDURE PERFORMED WAS LAPAROSCOPIC INGUINAL HERNIA REPAIR. IT IS REPORTED THAT THE BLADES SHOWED ISSUES CUTTING TISSUE EARLY IN THE CASE. THE SCISSORS WERE NOTED TO BE NON-FUNCTIONAL UPON INITIAL USE. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A WORKING PAIR OF SCISSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018047 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown