BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADLOCK CLIP, DEFECT CLOSURE SYSTEM

    MDR report key: 21221626 · Received January 22, 2025

    Report

    Report Number
    MW5165172
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    January 5, 2025
    Report Date
    January 17, 2025
    Manufacturer
    US ENDSCOPY / UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    PKL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN EMERGENT EGD(ESOPHAGOGASTRODUODENOSCOPY) WAS PERFORMED ON A PATIENT WITH A LIFE THREATENING PERFORATED GASTRIC ULCER WITH BLEEDING. THE PROVIDER USED THE PADLOCK CLIP TO TRY TO STOP THE BLEEDING. THE PROVIDER DEPLOYED THE FIRST PADLOCK CLIP SUCCESSFULLY AND WAS ABLE TO STOP THE BLEED. THE PROVIDER THEN TRIED TO PLACE A SECOND CLIP TO ANOTHER AREA AND THIS DEVICE FAILED AND BECAME DETACHED FROM THE EGD SCOPE, THE PADLOCK CLIP AND WIRE WERE RETAINED IN THE PATIENT'S STOMACH AND ESOPHAGUS. THE PATIENT HAD TO GO TO A HIGHER LEVEL OF CARE FOR REMOVAL OF THE PADLOCK CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607042 PADLOCK CLIP, DEFECT CLOSURE SYSTEM HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL US ENDSCOPY / UNITED STATES ENDOSCOPY GROUP, INC. C910001 5544834

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization ACETAMINOPHEN (TYLENOL) 500 MG TABLET| ALENDRONATE (FOSAMAX) 70 MG TABLET| ALENDRONATE (FOSAMAX) 70 MG TABLET | CALCIUM (1,250 MG) TABLET| CHOLECALCIFEROL MED | DOCUSATE SODIUM (COLACE) 100 MG| GLUC-CHON-MSM#1-C-MANG-BOS-BOR 750-625-30 MG TAB| LEVOTHYROXINE 100 MCG TABLET| LIDOCAINE HCL 4 % PTMD APPLY 1 PATCH TOPICALLY DAILY| MULTIVITAMIN WITH FOLIC ACID 400 MCG TABLET | SENNA-DOCUSATE (SENNA PLUS) 8.6-50 MG TABLET| SERTRALINE (ZOLOFT) 50 MG TABLET| VITAMIN A,C & E-LUTEIN-MINERALS (OCUVITE) 300 MCG-200 MG-27 MG-2 MG TABLET| VITAMIN D3, (VITAMIN D3) 1,000 UNIT TABLET