BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC ENDOCUFF

    MDR report key: 3635489 · Received February 19, 2014

    Report

    Report Number
    2150060-2014-00004
    Event Type
    Injury
    Date Received
    February 19, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 12, 2014
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED REVIEW OF 3500A REPORT SENT FROM (B)(4) TO THE MANUFACTURER, ARC MEDICAL: THANK YOU FOR FORWARDING THE MEDWATCH 3500 A FORM DETAILING AN ADVERSE EVENT ON (B)(4) 2004. WE HAVE CONSIDERED THE REPORT AND NOTE: THE PATIENT WAS (B)(6) OF AGE AND ANEMIC. THE PERFORATION WAS NOTED NEAR THE END-SIGMOID EXTRACTION AND THOSE PRESENT DID NOT ATTRIBUTE THIS TO THE ENDOCUFF. THE RISK OF PERFORATION IN COLONOSCOPY IS 1:1,000 -1,500 FOR DIAGNOSTIC PROCEDURES AND 1:500 FOR THERAPEUTIC PROCEDURES (EG POLYPECTOMY.) IT IS PROBABLY MORE COMMON IN THE ELDERLY. WE ARE UNAWARE OF ANY REPORTED INCIDENTS OF PERFORATION DURING ENDOCUFF ASSISTED COLONOSCOPY OR ANY INFORMATION WHICH MIGHT INDICATE THAT THE CONCLUSIONS REACHED BY THE TREATING CLINICIANS WERE INCORRECT. WE NOTE THAT (B)(4) WILL CONTINUE TO MONITOR THIS COMPLAINT AND SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, PLEASE FORWARD THIS TO US FOR FURTHER CONSIDERATION. WITH REGARD TO THE 3500 A FORM, WE HAVE NO SUGGESTED AMENDMENTS. WE HAVE FORWARDED THE FORM TO PRODUCT MANUFACTURERS, BODDINGTON PLASTICS LTD, TOGETHER WITH OUR OBSERVATIONS. KIND REGARDS, (B)(4), ARC MEDICAL DESIGN LIMITED.

    Description of Event or Problem · 1

    THE CASE STATE THAT THE PHYSICIAN WAS PERFORMING A COLONOSCOPY PROCEDURE USING AN ARC ENDOCUFF AEC120 WHEN A PERFORATION OF THE COLON OCCURED. THE CASE EVENTS STATE THAT THE PHYSICIAN REPORTED THAT THE PATIENT WAS (B)(6) AND ANEMIC. THE PHYSICIAN REPORTED HE DOESN'T THINK THE PERFORATION WAS SPECIFICALLY RELATED TO THE USE OF THE ENDOCUFF PRODUCT BUT WAS DUE TO THE ANATOMY OF A (B)(6) OLD COLON. THE PERFORATION WAS REALIZED IN THE COLON NEAR THE END-SIGMOID EXTRACTION. THE DOCTORS AND NURSES PERFORMING THE PROCEDURE DID NOT BLAME THE ENDOCUFF. THERE WAS LIMITED INFORMATION AS TO THE PATIENT'S CURRENT STATUS. IT WAS REPORTED HE WAS ADMITTED INTO SURGERY AFTER THE INCIDENT OF PERFORATION HAPPENED. IMPORTER NOTES, (B)(4). THE PHYSICIAN WAS TRIALING THE PRODUCT. THERE WERE MULTIPLE PROCEDURES BEFORE AND AFTER THIS PATIENT WHERE THE ENDOCUFF WAS USED AND THERE WAS NO ISSUES RELATIVE TO THE USE OF THE ENDOCUFF DURING THOSE PROCEDURES. (B)(4) SALES REPRESENTATIVE REPORTED THIS INCIDENT TO RA. THIS SALES REPRESENTATIVE HAS CONTINUED TO BE IN CLOSE CONTACT WITH THE CUSTOMER. (B)(4) BELIEVES THIS TO BE AN ISOLATED INCIDENT BEING THERE ARE NO RELATED COMPLAINTS WHILE USING THE ENDOCUFF ON PATIENTS OF THIS AGE AND THE COLON BEING IN AN ANEMIC CONDITION. (B)(4) WILL CONTINUE TO MONITOR THIS COMPLAINT. IT WILL BE MAINTAINED AND UPDATED WITHIN (B)(4) COMPLAINT SYSTEM FOR DOCUMENTATION PURPOSES. (B)(4) IS REPORTING AS AN IMPORTER ON BEHALF OF THE MANUFACTURER. ENDOCUFF IS A REGISTERED TRADEMARK OF ARC MEDICAL DESIGN. PRODUCT MANUFACTURED BY BODDINGTONS PLASTICS LTD. MANUFACTURER'S RESPONSE 3500A REPORT SENT FROM (B)(4) TO THE MANUFACTURER, ARC MEDICAL: THANK YOU FOR FORWARDING THE MEDWATCH 3500 A FORM DETAILING AN ADVERSE EVENT ON (B)(6) 2004. WE HAVE CONSIDERED THE REPORT AND NOTE: A. THE PATIENT WAS (B)(6) YEARS OF AGE AND ANEMIC. B. THE PERFORATION WAS NOTED NEAR THE END-SIGMOID EXTRACTION AND THOSE PRESENT DID NOT ATTRIBUTE THIS TO THE ENDOCUFF. THE RISK OF PERFORATION IN COLONOSCOPY IS 1:1,000 -1,500 FOR DIAGNOSTIC PROCEDURES AND 1:500 FOR THERAPEUTIC PROCEDURES (EG POLYPECTOMY.) IT IS PROBABLY MORE COMMON IN THE ELDERLY. WE ARE UNAWARE OF ANY REPORTED INCIDENTS OF PERFORATION DURING ENDOCUFF ASSISTED COLONOSCOPY OR ANY INFORMATION WHICH MIGHT INDICATE THAT THE CONCLUSIONS REACHED BY THE TREATING CLINICIANS WERE INCORRECT. WE NOTE THAT (B)(4) WILL CONTINUE TO MONITOR THIS COMPLAINT AND SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, PLEASE FORWARD THIS TO US FOR FURTHER CONSIDERATION. WITH REGARD TO THE 3500 A FORM, WE HAVE NO SUGGESTED AMENDMENTS. WE HAVE FORWARDED THE FORM TO PRODUCT MANUFACTURERS, BODDINGTON PLASTICS LTD, TOGETHER WITH OUR OBSERVATIONS. KIND REGARDS, (B)(4), ARC MEDICAL DESIGN LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106259 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC 120 WO-38315

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR ENDOSCOPE