BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADLOCK CLIP DEFECT CLOSURE DEVICE

    MDR report key: 7915969 · Received September 27, 2018

    Report

    Report Number
    1528319-2018-00032
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 31, 2018
    Report Date
    September 27, 2018
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    PKL
    UDI-DI
    00816765013809
    PMA / PMN Number
    K120814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PADLOCK DEVICE INDICATED FOR USE IN FLEXIBLE ENDOSCOPY AND FOR THE COMPRESSION OF TISSUE IN THE GASTROINTESTINAL TRACT, FOR HEMOSTASIS OR FOR TREATING LESIONS OF THE WALL OF THE GASTROINTESTINAL ORGANS. THE PADLOCK DEVICE IS INDICATED FOR CLIP PLACEMENT WITHIN THE GASTROINTESTINAL (GI) TRACT FOR THE PURPOSE OF: ENDOSCOPIC MARKING OF LESIONS HEMOSTASIS FOR: MUCOSAL/SUBMUCOSAL DEFECTS, BLEEDING ULCERS, ARTERIES <2MM, POLYPS <1.5CM IN DIAMETER, DIVERTICULA IN THE COLON CLOSURE OF GI TRACT LUMINAL PERFORATIONS <20MM THAT CAN BE TREATED CONSERVATIVELY. THE PADLOCK CLIP DEFECT CLOSURE SYSTEM CONSISTS OF A SINGLE USE CLIP WITHIN A MECHANICAL DELIVERY SYSTEM. THE PADLOCK CLIP DEFECT CLOSURE SYSTEM IS MOUNTED AND SECURED AT THE DISTAL TIP ON THE OUTSIDE SURFACE OF A FLEXIBLE ENDOSCOPE. THE CLIP WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN WAS UNSURE WHETHER THE DELIVERY COMPONENT DETACHED DURING SCOPE WITHDRAWAL OR AT THE TIME OF CLIP DEPLOYMENT. IT WAS NOTED THAT THE PATIENT'S ESOPHAGUS WAS NARROW AND TIGHT, AND ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR IN THIS EVENT. THE DEVICE HISTORY RECORD (LOT 1810886, MANUFACTURED JUNE 2018, (B)(4) UNITS) WAS REVIEWED AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. THE DEVICE SUBJECT OF THIS EVENT WAS NOT RETURNED TO US ENDOSCOPY FOR EVALUATION. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "USE CAUTION AND DO NOT FORCE ENDOSCOPE LOADED WITH PADLOCK CLIP DELIVERY SYSTEM THROUGH ANY STENOSIS OR ANY AREA OF KNOWN UNDERSIZED ANATOMY. PERFORM INITIAL SURVEILLANCE ENDOSCOPY TO UNCOVER ANY ANATOMICAL CONCERNS AND LOCATION OF DEFECT TO BE TREATED PRIOR TO USING THE PADLOCK CLIP DEFECT CLOSURE SYSTEM. CHECK TO ENSURE THAT THE SCOPE IS INSERTED COMPLETELY INTO THE SCOPE MOUNTING FEATURE OF THE DELIVERY HOUSING AND THAT THE HOUSING ISN'T EXPANDED. CHECK TO ENSURE THAT THE SCOPE IS INSERTED COMPLETELY INTO THE SCOPE MOUNTING FEATURE OF THE DELIVERY HOUSING AND THAT THERE IS NO GAP ON THE OPEN SIDE WHERE THE SCOPE AND DISTAL HOUSING MEET. " IN-SERVICE TRAINING WAS COMPLETED ON 8/31/2018. THERE HAVE BEEN NO FURTHER REPORTED ISSUES SINCE IN-SERVICE WAS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT, FOLLOWING USAGE IN A PROCEDURE, THE PADLOCK DEVICE DELIVERY COMPONENT SEPARATED FROM THE END OF THE ENDOSCOPE. A GRASPING DEVICE WAS USED TO RETRIEVE THE DELIVERY COMPONENT AND THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER DUE TO THE COMPONENT SEPARATION NOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758081 PADLOCK CLIP DEFECT CLOSURE DEVICE DEFECT CLOSURE DEVICE PKL UNITED STATES ENDOSCOPY GROUP, INC. C913131 1810886 00816765013809

    Patients

    Seq Age Sex Outcome Treatment
    1