BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13256249 · Received January 13, 2022

    Report

    Report Number
    2027111-2022-00319
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 18, 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
    TX, US
    Reporter Occupation
    003

    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 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.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. DETAILED DESCRIPTION OF EVENT: REP WAS NOT PRESENT IN THE CASE WHEN TWO UNITS OF CB030 WOULD NOT CUT DURING USE. BOTH UNITS WERE COMPLAINED TO HAVE SPACE BETWEEN THE PROXIMAL ENDS OF THE BLADES AND ONLY TOUCHED AT THE BLADE TIPS WHEN IN THE CLOSED POSITION. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A THIRD CB030. ONE UNIT OF CB030 IS AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH A THIRD CB030.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: #2021-002958 [MFR # 2027111-2022-00319], COMPLAINT 2 OF 2: #2021-002961 [MFR # 2027111-2022-00320]. REP WAS NOT PRESENT IN THE CASE WHEN TWO UNITS OF CB030 WOULD NOT CUT DURING USE. BOTH UNITS WERE COMPLAINED TO HAVE SPACE BETWEEN THE PROXIMAL ENDS OF THE BLADES AND ONLY TOUCHED AT THE BLADE TIPS WHEN IN THE CLOSED POSITION. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A THIRD CB030. ONE UNIT OF CB030 IS AVAILABLE FOR RETURN. PATIENT STATUS: THERE WAS NO PATIENT INJURY. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH A THIRD CB030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834842 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1430040 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown