BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC ENDOCUFF

    MDR report key: 3888668 · Received October 18, 2013

    Report

    Report Number
    2150060-2013-00012
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    October 18, 2013
    Report Date
    October 23, 2013
    Manufacturer
    BODDINGTONS PLASTICS LTD.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED AN ENDOSCOPY PROCEDURE ON A PATIENT PREVIOUSLY DIAGNOSED WITH DIVERTICULITIS USING ARC ENDOCUFF AEC120. PHYSICIAN REPORTED THE PATIENT HAD A TIGHT COLON. DURING THE PROCEDURE, THE PHYSICIAN FELT THAT THE ENDOCUFF ON THE END OF THE SCOPE WAS IMPEDING HIS PROGRESS FORWARD AND DECIDED TO WITHDRAW SCOPE TO REMOVE ENDOCUFF. AS THE PHYSICIAN WAS RETRACTING THE SCOPE FROM THE PATIENT'S COLON, THE HAIRS OF THE ENDOCUFF FLARE IN THE BACKWARD POSITION RUBBING AGAINST THE COLON WALL. PICTURES INDICATE A SMALL ABRASION OCCURRED DURING THE RETRACTION OF SCOPE AND ENDOCUFF COMBINATION. PHYSICIAN REMOVED THE ENDOCUFF AND PROCEED WITH THE PROCEDURE. THE PHYSICIAN DID NOT FEEL IMMEDIATE REPAIR WAS NECESSARY IN CONTINUED WITH PRESCRIBING THE PATIENT TO A FLUID DIET. AFTER COMPLETING PROCEDURE, THE PATIENT WAS RELEASED ON AN OUTPATIENT STATUS. IMPORTER NOTES, MEDIVATORS, INC.: PATIENT WAS RELEASED AFTER PROCEDURE. NO FURTHER MEDICAL ATTENTION HAS BEEN REPORTED. MEDIVATORS HAS CONFIRMATION THAT 3-4 PROCEDURES WERE DONE PRIOR TO THIS INCIDENT USING AN ENDOCUFF FROM THE SAME LOT NUMBER AND THERE WERE NO ISSUES DURING THE PROCEDURES. MEDIVATORS SALES AND CLINICAL SPECIALISTS HAVE CONTINUED TO BE IN CLOSE CONTACT WITH THE CUSTOMER. MEDIVATORS HAS OFFERED CONTINUED SUPPORT AND ASSISTANCE AS THE CUSTOMER REQUESTS. MEDIVATORS IS REPORTING AS AN IMPORTER ON BEHALF OF THE MANUFACTURER. MEDIVATORS BELIEVES THIS TO BE AN ISOLATED INCIDENT BEING THERE ARE NO RELATED COMPLAINTS FROM THE SAME LOT NUMBER OF THE ENDOCUFF OR DIFFERENT LOT NUMBER OF THE ENDOCUFF PRODUCT ALONG WITH EVIDENCE OF THE PATIENT'S PRE-DETERMINED CONDITION PRIOR TO PERFORMING THE PROCEDURE. MEDIVATORS WILL CONTINUE TO MONITOR THIS COMPLAINT. IT WILL BE MAINTAINED AND UPDATED WITHIN MEDIVATORS COMPLAINT SYSTEM FOR DOCUMENTATION PURPOSES. MEDIVATORS IS REPORTING AS AN IMPORTER ON BEHALF OF THE MANUFACTURER. (B)(4). PRODUCT MANUFACTURED BY BODDINGTONS PLASTICS LTD. PLEASE REFERENCE ATTACHED "RESPONSE REPORT: INCIDENT ANALYSIS" PROVIDED BY ARC MEDICAL DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537494 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD. AEC120 WO-35571

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR