BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13596057 · Received February 24, 2022

    Report

    Report Number
    2027111-2022-00405
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    January 21, 2022
    Report Date
    April 27, 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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION BUT LOT NUMBER IS PROVIDED. 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: NO INFORMATION. DETAILED DESCRIPTION OF EVENT: CUSTOMER COMPLAINS THAT CB030 IS "DULL". ADDITIONAL INFORMATION RECEIVED VIA EMAIL 28-JAN-2022 FROM [NAME], PURCHASING AGENT: THE INCIDENT OCCURRED PRIOR TO PROCEDURE. THE DOCTOR USED ANOTHER ITEM TO PERFORM PROCEDURE. NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 03-FEB-2022 FROM [NAME], PURCHASING AGENT:: CUSTOMER INFORMS THAT THE PRODUCT IS RETURNING. EVENT DATE IS ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 17-FEB-2022 FROM [NAME], PURCHASING AGENT: MY APOLOGIES THERE WAS A MISUNDERSTANDING, PRODUCT IS NOT BEING RETURNED. PATIENT STATUS: NO PATIENT INJURY OCCURRED. INTERVENTION THE DOCTOR USED ANOTHER ITEM TO PERFORM PROCEDURE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NO INFORMATION. EVENT DESCRIPTION: CUSTOMER COMPLAINS THAT CB030 IS "DULL". ADDITIONAL INFORMATION RECEIVED VIA EMAIL 28JAN2022 FROM [NAME], PURCHASING AGENT: THE INCIDENT OCCURRED PRIOR TO PROCEDURE. THE DOCTOR USED ANOTHER ITEM TO PERFORM PROCEDURE. NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 03FEB2022 FROM [NAME], PURCHASING AGENT: CUSTOMER INFORMS THAT THE PRODUCT IS RETURNING. EVENT DATE IS 21JAN2022. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 17FEB2022 FROM [NAME], PURCHASING AGENT: MY APOLOGIZES THERE WAS A MISUNDERSTANDING, PRODUCT IS NOT BEING RETURNED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 25FEB2022 FROM [NAME], PURCHASING AGENT: IT IS UNKNOWN HOW THE USER WAS ABLE TO TEST BLADE DULLNESS PRIOR TO PROCEDURE. INTERVENTION: THE DOCTOR USED ANOTHER ITEM TO PERFORM PROCEDURE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195745 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1434543 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown