BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X 1.535 STERILE

    MDR report key: 17380207 · Received July 24, 2023

    Report

    Report Number
    1836161-2023-00023
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 7, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM A CUSTOMER INDICATING THAT THE SURGICAL NEEDLE BROKE WHILE IN USE. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS NOT PROVIDED FOR REVIEW. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE 3RD ACKNOWLEDGEMENT FOR REPORT# 1836161-2023-00023 WAS NEVER RECEIVED. THEREFORE WE ARE SUBMITTING AGAIN AS A FOLLOW UP TO BE SURE THAT THE REPORTS WERE RECIEVED.

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE CUSTOMER INDICATING THAT THE SURGICAL NEEDLE BROKE WHILE IN USE. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS NOT PROVIDED FOR REVIEW. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE CUSTOMER INDICATING THAT A SURGICAL NEEDLE BROKE WHILE IN USE. NO INJURY OR DEATH WAS REPORTED. THIS EVENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS # (B)(4).

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE CUSTOMER INDICATING THAT A SURGICAL NEEDLE BROKE WHILE IN USE. NO INJURY/DEATH WAS REPORTED. THIS EVENT WAS FILED IN OUR COMPLIANT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423358 NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X 1.535 STERILE SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS 217003 274133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown