BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON APPLIER, MICRO, CURVED, 8"

    MDR report key: 12961546 · Received December 8, 2021

    Report

    Report Number
    3011137372-2021-00338
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    November 25, 2021
    Report Date
    November 25, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PER CUSTOMER SUBMITTED INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE ALLEGED DEFECTIVE INSTRUMENT WAS MANUFACTURED OR PERFORM A THOROUGH DHR REVIEW SINCE LOT INFORMATION HAS NOT BEEN PROVIDED. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE ALLEGED DEFECT OR VALIDATE THE ALLEGED COMPLAINT. ALL INSTRUMENTS OF THIS TYPE WHICH ARE MANUFACTURED AT TECOMET, INC. ARE 100 % VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO RELEASE TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 537081. ISOLATED INCIDENT. THE REFERENCED DEVICE LOT WAS DISTRIBUTED OVER 10 YEARS AGO. THIS INSTRUMENT APPLIES A LIGATING CLIP WITH PARALLEL CLOSURE. THIS DEVICE REQUIRES ROUTINE SERVICE FOR OPTIMAL PERFORMANCE. THE ONLY OPPORTUNITY FOR VESSEL DAMAGE IS MISALIGNED JAWS RESULTING FROM LACK OF SERVICE, PHYSICAL DAMAGE, OR IMPROPER USE OF THE APPLIER. A REVIEW OF THE ACTUAL PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 537081. ISOLATED INCIDENT. THE REFERENCED DEVICE LOT WAS DISTRIBUTED OVER 10 YEARS AGO. THIS INSTRUMENT APPLIES A LIGATING CLIP WITH PARALLEL CLOSURE. THIS DEVICE REQUIRES ROUTINE SERVICE FOR OPTIMAL PERFORMANCE. THE ONLY OPPORTUNITY FOR VESSEL DAMAGE IS MISALIGNED JAWS RESULTING FROM LACK OF SERVICE, PHYSICAL DAMAGE, OR IMPROPER USE OF THE APPLIER.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    A SURGEON HAD ISSUES WITH OUR 537081 APPLIERS. THEY DAMMAGE THE VESSELS.

    Description of Event or Problem · 0

    A SURGEON HAD ISSUES WITH OUR 537081 APPLIERS. THEY DAMAGED THE VESSELS.

    Description of Event or Problem · 0

    A SURGEON HAD ISSUES WITH OUR 537081 APPLIERS. THEY DAMAGE THE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862945 HORIZON APPLIER, MICRO, CURVED, 8" APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN008965 06L1159678 24026704696639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown