BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERISEAL SURGICAL NEEDLE

    MDR report key: 7503626 · Received May 10, 2018

    Report

    Report Number
    1836161-2018-00043
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE (B)(6) ((B)(4)) INDICATING A STERISEAL SURGICAL NEEDLE SEPARATED DURING A PROCEDURE. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE MANUFACTURING LOT NUMBER AND PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW. THE REPORT FROM THE (B)(6) INDICATED THAT THE END USER EXPERIENCED THE SUPERIOR ASPECT OF THE EYE OF NEEDLE (THE BIT THROUGH WHICH THE SUTURE IS PASSED) BROKE WHILE SUTURING. THE MISSING SUPERIOR PORTION OF THE NEEDLE COULD NOT BE SEEN OR PALPATED IN THE TISSUES WHICH WERE BEING SUTURED. THE AREA WAS VISUALLY INSPECTED AND NO FRAGMENTS WERE FOUND. THE PATIENT UNDERWENT X-RAY TO DETERMINE THE LOCATION OF THE MISSING PIECE. NO EVIDENCE OF FRAGMENTS OF NEEDLE WERE DISCOVERED. THE PATIENT HAD NO ADVERSE EFFECTS. ANALYSIS RESULT OF THE FINISHED GOOD LOT NUMBER 061580 WAS REVIEWED. NO NON-CONFORMANCE'S WERE NOTED IN THE DHR. THE PHOTO CONFIRMED THE CONDITION OF THE BROKEN NEEDLE. ACCORDING TO ASPEN SURGICAL'S IFU, THE NEEDLES SHOULD NOT BE CLAMPED DIRECTLY ON THE EYE OF THE NEEDLE TO THE POINT AND SHOULD BE APPLIED TO THE FLAT PORTION OF THE NEEDLE ABOUT 1/4 OF THE NEEDLE LENGTH FROM THE EYE END. HOWEVER, THE ROOT CAUSE OF THE BREAK COULD NOT BE CURRENTLY DETERMINED THROUGH THE EVALUATION OF THE PHOTO AND DOCUMENTATION REVIEW. ADDITIONALLY, THIS PRODUCT LINE WAS DISCONTINUED IN 2016 WITH MANUFACTURE TRANSFER FROM (B)(6) TO (B)(4). BASED ON THIS INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE (B)(4) (REF: (B)(4)) INDICATING A STERISEAL SURGICAL NEEDLE SEPARATED DURING A PROCEDURE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4) .

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE (B)(6) ((B)(4)) INDICATING A STERISEAL SURGICAL NEEDLE SEPARATED DURING A PROCEDURE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345376 STERISEAL SURGICAL NEEDLE SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, CALEDONIA SN1320 061580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R