BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON TI SMALL 6/CART 180/BOX

    MDR report key: 12836657 · Received November 18, 2021

    Report

    Report Number
    3011137372-2021-00317
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 10, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704709940
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4) THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 100-PIECE LOT IN NOVEMBER OF 2018. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT IT HAS BEEN SENT IN FOR REPAIR AT SOME POINT SINCE ITS EXTERIOR FINISH IS BEAD BLASTED AND NOT SATIN BRUSHED FINISH AS PRODUCED AND IT HAS ADDITIONAL CODING ON THE DOUBLE STEM OF THE HANDLE OF AF21/20. FURTHER EVALUATION SHOWS THAT THERE IS NO DAMAGE TO THE TIPS, AND THEY ARE ALIGNED IN THE OPEN AND CLOSED POSITIONS. FUNCTIONAL TESTING AS PERFORMED AT TIME OF MANUFACTURE SHOWS THAT THIS INSTRUMENT IS ABLE TO PICK-UP, RETAIN, CLOSE AND RELEASE MULTIPLE CLIPS. LEG AND EYE GAP MEASUREMENT'S MEASURED WITHIN HORIZON CLIP SPECIFICATIONS OF .0030" MAX LEG GAP AT (.0005"-.0012") AND .0042" MAX. EYE GAP AT (.0002-.0003"). WE ARE UNABLE TO DETERMINE WHAT CAUSED THE ALLEGED DEFECT AT THE END USER'S FACILITY. ALL 100 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED AT A 1.0 AQL PRIOR TO SHIPMENT 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). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    INCIDENT HAPPENED ON THE (B)(6) 2021 IN SURGERY ROOM. DURING A THYROID SURGERY THE DOCTOR HAD TO USE A BLUE TITANIUM CLIP REF (B)(4) 0 LOT 73J2000654. THE CLIP DID NOT HOLD ON THE THYROID ARTERY. THIS CLIP GOT STUCK ON ONE OF THE JAWS THE HORIZON MEDIUM CLIP PLIERS 237081 LOT 06K1757772. THAT INJURED THE ARTERY WHEN THE SURGEON REMOVED THE APPLIER CAUSING SIGNIFICANT BLEEDING. FACING THIS URGENCY SITUATION, THE SURGEON USED A SMALLER HEMOSTASIS FORCEPS CAT # 137081 + CLIP 001200 LOT# 73J2000649, WHICH CAUSED A LOSS OF SIGNAL FROM THE RECURRENT NERVE WHICH CONTROLS VOICE FUNCTION. THE SURGEON STATED THAT THE SAME INCIDENT HAPPENED WITH THE SMALLER APPLIER LIGATION FAILURE. CONSEQUENCE: PER-OPERATIVE BLEEDING AND POSSIBLE RECURRENT NERVE DAMAGE. THIS PROBLEM HAS OCCURRED SEVERAL TIMES WITHOUT CONSEQUENCE FOR PATIENTS. EACH TIME WE CHANGED THE APPLIER AND FOR THIS INCIDENT THE APPLIER HAD BEEN CHANGED 15 DAYS BEFORE. SINCE THIS INCIDENT SALES REPRESENTATIVE WENT ON SITE ON MONDAY 08 NOVEMBER AND CHANGED APPLIERS. THE PATIENT'S CONDITION IS FINE. THE RECURRENT NERVE IS NON-FUNCTIONAL POSTOPERATIVELY. THERE WERE NO UNDERLYING MEDICAL CONDITIONS. THE REPORTED CLIPS AND APPLIER WERE CONFIRMED.

    Description of Event or Problem · 0

    INCIDENT HAPPENED ON THE (B)(6) 2021 IN SURGERY ROOM. DURING A THYROID SURGERY THE DOCTOR HAD TO USE A BLUE TITANIUM CLIP REF 002200 LOT 73J2000654. THE CLIP DID NOT HOLD ON THE THYROID ARTERY. THIS CLIP GOT STUCK ON ONE OF THE JAWS THE HORIZON MEDIUM CLIP PLIERS 237081 LOT 06K1757772. THAT INJURED THE ARTERY WHEN THE SURGEON REMOVED THE APPLIER CAUSING SIGNIFICANT BLEEDING. FACING THIS URGENCY SITUATION, THE SURGEON USED A SMALLER HEMOSTASIS FORCEPS CAT # 137081 + CLIP 001200 LOT# 73J2000649, WHICH CAUSED A LOSS OF SIGNAL FROM THE RECURRENT NERVE WHICH CONTROLS VOICE FUNCTION. THE SURGEON STATED THAT THE SAME INCIDENT HAPPENED WITH THE SMALLER APPLIER LIGATION FAILURE. CONSEQUENCE: PER-OPERATIVE BLEEDING AND POSSIBLE RECURRENT NERVE DAMAGE. THIS PROBLEM HAS OCCURRED SEVERAL TIMES WITHOUT CONSEQUENCE FOR PATIENTS. EACH TIME WE CHANGED THE APPLIER AND FOR THIS INCIDENT THE APPLIER HAD BEEN CHANGED 15 DAYS BEFORE. SINCE THIS INCIDENT SALES REPRESENTATIVE WENT ON SITE ON MONDAY 08 NOVEMBER AND CHANGED APPLIERS. THE PATIENT'S CONDITION IS FINE. THE RECURRENT NERVE IS NON-FUNCTIONAL POSTOPERATIVELY. THERE WERE NO UNDERLYING MEDICAL CONDITIONS. THE REPORTED CLIPS AND APPLIER WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736626 HORIZON TI SMALL 6/CART 180/BOX APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN914937 UNKNOWN 24026704709940

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown Required Intervention