BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOL ML 5 MILLIMETER ENDO APPLIER

    MDR report key: 10490763 · Received September 3, 2020

    Report

    Report Number
    3011137372-2020-00205
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 15, 2020
    Report Date
    August 19, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 50 PC. LOT IN MARCH OF 2016. THE INSTRUMENT AS RETURNED WAS EVALUATED AND FOUND THAT THE KNOB ROTATION MECHANISM IS DRY AND SLUGGISH SIGNIFYING THAT THIS INSTRUMENT IS IN NEED OF PROPER LUBRICATION, BUT THE HANDLE TO JAW MECHANISM WAS NOT DRY AND SLUGGISH FEELING. AFTER INITIAL EVALUATION AND FUNCTION TESTING THIS INSTRUMENT WAS LUBRICATED USING NON-SILICONE BASED INSTRUMENT LUBE AS INSTRUCTED IN THE IFU (L06109 R.04) WHICH WAS SUPPLIED WITH THE INSTRUMENT AT TIME OF MANUFACTURE AND THE KNOB ROTATION MECHANISM FEEL WAS RESTORED TO MINIMAL ROTATIONAL FORCE NEEDED TO ROTATE. THIS INSTRUMENT WAS DISASSEMBLED FOR FURTHER EVALUATION AND IT WAS FOUND THAT THE DRIVE ROD FINGERS (N00185) THAT ACTUATE THE JAWS ARE DAMAGED. WE ARE ABLE TO VALIDATE THIS COMPLAINT SINCE IT IS LIKELY THAT THE DAMAGED DRIVE ROD FINGERS AND DRY KNOB ROTATIONAL MECHANISM COULD HAVE CAUSED THIS INSTRUMENT TO NOT FUNCTION PROPERLY. WE ARE UNABLE TO DETERMINE AS TO HOW THE DRIVE ROD FINGERS BECAME DAMAGED AND FOR THE KNOB ROTATION MECHANISM TO BECOME DRY AND SLUGGISH BUT MISHANDLING AND LACK OF PROPER LUBRICATION OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED. ALL 50 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THE PRODUCT LINE.

    Description of Event or Problem · 0

    ISSUE REPORTED: SURGEON WAS USING THE DEVICE IN A LAP CHOLE AND FIRED ONE CLIP ONTO THE CYSTIC ARTERY. HE WENT TO PLACE THE SECOND CLIP ON THE ARTERY AND THE CLIP APPLIER LOCKED OVER THE ARTERY AND WOULD NOT OPEN. HE TRIED TO WISHBONE THE HANDLE TO RELEASE THE JAWS BUT WAS UNABLE TO DO SO. HE EVENTUALLY USED ANOTHER APPLIER TO PLACE ANOTHER CLIP AND THEN CUT OUT THE SECTION WITH THE APPLIER LOCKED ONTO IT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ISSUE REPORTED: SURGEON WAS USING THE DEVICE IN A LAP CHOLE AND FIRED ONE CLIP ONTO THE CYSTIC ARTERY. HE WENT TO PLACE THE SECOND CLIP ON THE ARTERY AND THE CLIP APPLIER LOCKED OVER THE ARTERY AND WOULD NOT OPEN. HE TRIED TO WISHBONE THE HANDLE TO RELEASE THE JAWS BUT WAS UNABLE TO DO SO. HE EVENTUALLY USED ANOTHER APPLIER TO PLACE ANOTHER CLIP AND THEN CUT OUT THE SECTION WITH THE APPLIER LOCKED ONTO IT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952515 HOL ML 5 MILLIMETER ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R